Trial Outcomes & Findings for Cemented Versus Cementless Unicompartmental Knee Arthroplasty (NCT NCT05935878)
NCT ID: NCT05935878
Last Updated: 2024-09-23
Results Overview
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
COMPLETED
NA
47 participants
Patients will be examined 3 months post surgery.
2024-09-23
Participant Flow
A consecutive series of patients awairing an Oxford Unicompartmental Knee Replacement (OUKR) were invited to participate in the study. Consenting participants received an OUKR between November 2008 and March 2010 at the Nuffield Orthopaedic Centre (Oxford, UK).
Participant milestones
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
1 Year
|
22
|
21
|
|
Overall Study
2 Years
|
22
|
21
|
|
Overall Study
5 Years
|
19
|
20
|
|
Overall Study
10 Years
|
16
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Revision of implant
|
1
|
1
|
|
Overall Study
Mobile bearing dislocation
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=23 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=24 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=47 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=23 Participants
|
11 Participants
n=24 Participants
|
19 Participants
n=47 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=23 Participants
|
13 Participants
n=24 Participants
|
28 Participants
n=47 Participants
|
|
Age, Continuous
|
67.7 years
n=23 Participants
|
65.9 years
n=24 Participants
|
66.7 years
n=47 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants
|
12 Participants
n=24 Participants
|
21 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants
|
12 Participants
n=24 Participants
|
26 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
23 participants
n=23 Participants
|
24 participants
n=24 Participants
|
47 participants
n=47 Participants
|
PRIMARY outcome
Timeframe: Patients will be examined 3 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Translations
Femoral X Migration
|
-0.01 millimetres
Standard Deviation 0.36
|
0.05 millimetres
Standard Deviation 0.40
|
|
Radiostereometric Analysis Examination - Translations
Femoral Y Migration
|
-0.10 millimetres
Standard Deviation 0.34
|
-0.17 millimetres
Standard Deviation 0.25
|
|
Radiostereometric Analysis Examination - Translations
Femoral Z Migration
|
0.26 millimetres
Standard Deviation 0.48
|
0.14 millimetres
Standard Deviation 0.33
|
|
Radiostereometric Analysis Examination - Translations
Tibial X Migration
|
-0.09 millimetres
Standard Deviation 0.22
|
0.08 millimetres
Standard Deviation 0.28
|
|
Radiostereometric Analysis Examination - Translations
Tibial Y Migration
|
-0.23 millimetres
Standard Deviation 0.18
|
-0.10 millimetres
Standard Deviation 0.17
|
|
Radiostereometric Analysis Examination - Translations
Tibial Z Migration
|
-0.03 millimetres
Standard Deviation 0.20
|
-0.02 millimetres
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Patients will be examined 6 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Translations
Femoral X Migration
|
-0.12 millimetres
Standard Deviation 0.31
|
0.05 millimetres
Standard Deviation 0.28
|
|
Radiostereometric Analysis Examination - Translations
Femoral Y Migration
|
-0.02 millimetres
Standard Deviation 0.39
|
-0.02 millimetres
Standard Deviation 0.39
|
|
Radiostereometric Analysis Examination - Translations
Femoral Z Migration
|
0.24 millimetres
Standard Deviation 0.39
|
0.16 millimetres
Standard Deviation 0.29
|
|
Radiostereometric Analysis Examination - Translations
Tibial X Migration
|
0.06 millimetres
Standard Deviation 0.19
|
0.06 millimetres
Standard Deviation 0.19
|
|
Radiostereometric Analysis Examination - Translations
Tibial Y Migration
|
-0.28 millimetres
Standard Deviation 0.17
|
0.06 millimetres
Standard Deviation 0.18
|
|
Radiostereometric Analysis Examination - Translations
Tibial Z Migration
|
-0.03 millimetres
Standard Deviation 0.13
|
-0.05 millimetres
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Patients will be examined 12 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Translations
Femoral X Translation
|
-0.18 millimetres
Standard Deviation 0.28
|
0.05 millimetres
Standard Deviation 0.28
|
|
Radiostereometric Analysis Examination - Translations
Femoral Y Translation
|
-0.12 millimetres
Standard Deviation 0.24
|
-0.12 millimetres
Standard Deviation 0.25
|
|
Radiostereometric Analysis Examination - Translations
Femoral Z Translation
|
0.26 millimetres
Standard Deviation 0.31
|
0.24 millimetres
Standard Deviation 0.32
|
|
Radiostereometric Analysis Examination - Translations
Tibial X Translation
|
-0.04 millimetres
Standard Deviation 0.21
|
0.01 millimetres
Standard Deviation 0.24
|
|
Radiostereometric Analysis Examination - Translations
Tibial Y Translation
|
-0.28 millimetres
Standard Deviation 0.19
|
-0.09 millimetres
Standard Deviation 0.19
|
|
Radiostereometric Analysis Examination - Translations
Tibial Z Translation
|
-0.01 millimetres
Standard Deviation 0.15
|
0.00 millimetres
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Patients will be examined 24 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Translations
Femoral X Translation
|
-0.05 millimetres
Standard Deviation 0.53
|
0.03 millimetres
Standard Deviation 0.34
|
|
Radiostereometric Analysis Examination - Translations
Femoral Y Translation
|
-0.04 millimetres
Standard Deviation 0.27
|
-0.05 millimetres
Standard Deviation 0.32
|
|
Radiostereometric Analysis Examination - Translations
Femoral Z Translation
|
0.21 millimetres
Standard Deviation 0.23
|
0.22 millimetres
Standard Deviation 0.42
|
|
Radiostereometric Analysis Examination - Translations
Tibial X Translation
|
0.01 millimetres
Standard Deviation 0.19
|
0.06 millimetres
Standard Deviation 0.26
|
|
Radiostereometric Analysis Examination - Translations
Tibial Y Translation
|
-0.34 millimetres
Standard Deviation 0.23
|
-0.13 millimetres
Standard Deviation 0.23
|
|
Radiostereometric Analysis Examination - Translations
Tibial Z Translation
|
-0.02 millimetres
Standard Deviation 0.16
|
0.03 millimetres
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: Patients will be examined 60 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=19 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=20 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Translations
Tibial X Translation
|
-0.03 millimetres
Standard Deviation 0.21
|
0.03 millimetres
Standard Deviation 0.22
|
|
Radiostereometric Analysis Examination - Translations
Femoral X Translation
|
-0.02 millimetres
Standard Deviation 0.46
|
0.10 millimetres
Standard Deviation 0.35
|
|
Radiostereometric Analysis Examination - Translations
Femoral Y Translation
|
-0.07 millimetres
Standard Deviation 0.29
|
-0.16 millimetres
Standard Deviation 0.19
|
|
Radiostereometric Analysis Examination - Translations
Femoral Z Translation
|
0.14 millimetres
Standard Deviation 0.31
|
0.20 millimetres
Standard Deviation 0.30
|
|
Radiostereometric Analysis Examination - Translations
Tibial Y Translation
|
-0.28 millimetres
Standard Deviation 0.19
|
-0.14 millimetres
Standard Deviation 0.29
|
|
Radiostereometric Analysis Examination - Translations
Tibial Z Translation
|
0.00 millimetres
Standard Deviation 0.11
|
0.01 millimetres
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: Patients will be examined 120 months post surgery.Population: 1 Cemented Oxford Unicompartmental Knee Arthroplasty could not be analysed due poor quality stereoradiographs with obstruction of bone markers being obstructed. Consequently, although 15 Cemented Oxford Unicompartmental Knee Arthroplasties were followed-up at 120 months, only 14 could be analysed.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=16 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=14 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Translations
Femoral X Translation
|
-0.12 millimetres
Standard Deviation 0.50
|
0.24 millimetres
Standard Deviation 0.31
|
|
Radiostereometric Analysis Examination - Translations
Femoral Y Translation
|
-0.14 millimetres
Standard Deviation 0.27
|
-0.16 millimetres
Standard Deviation 0.21
|
|
Radiostereometric Analysis Examination - Translations
Femoral Z Translation
|
0.20 millimetres
Standard Deviation 0.36
|
0.14 millimetres
Standard Deviation 0.28
|
|
Radiostereometric Analysis Examination - Translations
Tibial X Translation
|
0.00 millimetres
Standard Deviation 0.26
|
0.00 millimetres
Standard Deviation 0.16
|
|
Radiostereometric Analysis Examination - Translations
Tibial Y Translation
|
-0.29 millimetres
Standard Deviation 0.20
|
-0.15 millimetres
Standard Deviation 0.42
|
|
Radiostereometric Analysis Examination - Translations
Tibial Z Translation
|
-0.01 millimetres
Standard Deviation 0.21
|
0.02 millimetres
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: Patients will be examined at 3 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: \*For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus \*For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Rotations
Femoral X Rotation
|
0.22 Degrees
Standard Deviation 0.95
|
0.19 Degrees
Standard Deviation 0.47
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Y Rotation
|
0.26 Degrees
Standard Deviation 0.55
|
0.10 Degrees
Standard Deviation 0.74
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Z Rotation
|
-0.16 Degrees
Standard Deviation 0.89
|
-0.10 Degrees
Standard Deviation 0.95
|
|
Radiostereometric Analysis Examination - Rotations
Tibial X Rotation
|
-0.48 Degrees
Standard Deviation 0.88
|
-0.09 Degrees
Standard Deviation 0.50
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Y Rotation
|
0.05 Degrees
Standard Deviation 0.63
|
-0.08 Degrees
Standard Deviation 0.46
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Z Rotation
|
0.36 Degrees
Standard Deviation 0.70
|
-0.10 Degrees
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: Patients will be examined at 6 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Rotations
Femoral X Rotation
|
0.04 Degrees
Standard Deviation 0.56
|
0.27 Degrees
Standard Deviation 0.81
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Y Rotation
|
0.48 Degrees
Standard Deviation 0.79
|
0.05 Degrees
Standard Deviation 0.62
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Z Rotation
|
-0.11 Degrees
Standard Deviation 0.90
|
0.19 Degrees
Standard Deviation 0.76
|
|
Radiostereometric Analysis Examination - Rotations
Tibial X Rotation
|
-0.46 Degrees
Standard Deviation 0.78
|
-0.25 Degrees
Standard Deviation 0.65
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Y Rotation
|
0.12 Degrees
Standard Deviation 0.58
|
0.07 Degrees
Standard Deviation 0.36
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Z Rotation
|
0.33 Degrees
Standard Deviation 0.71
|
0.15 Degrees
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: Patients will be examined at 12 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Rotations
Femoral X Rotation
|
0.22 Degrees
Standard Deviation 0.57
|
0.16 Degrees
Standard Deviation 0.65
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Y Rotation
|
0.24 Degrees
Standard Deviation 0.52
|
-0.05 Degrees
Standard Deviation 0.63
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Z Rotation
|
-0.26 Degrees
Standard Deviation 0.93
|
0.25 Degrees
Standard Deviation 0.80
|
|
Radiostereometric Analysis Examination - Rotations
Tibial X Rotation
|
-0.38 Degrees
Standard Deviation 0.73
|
-0.10 Degrees
Standard Deviation 0.70
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Y Rotation
|
0.16 Degrees
Standard Deviation 0.54
|
-0.02 Degrees
Standard Deviation 0.45
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Z Rotation
|
0.10 Degrees
Standard Deviation 0.63
|
-0.29 Degrees
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: Patients will be examined at 24 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Rotations
Femoral X Migration
|
0.20 Degrees
Standard Deviation 0.54
|
0.23 Degrees
Standard Deviation 0.68
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Y Migration
|
0.23 Degrees
Standard Deviation 0.52
|
0.32 Degrees
Standard Deviation 0.52
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Z Migration
|
0.00 Degrees
Standard Deviation 1.28
|
-0.06 Degrees
Standard Deviation 0.75
|
|
Radiostereometric Analysis Examination - Rotations
Tibial X Migration
|
-0.40 Degrees
Standard Deviation 0.76
|
-0.17 Degrees
Standard Deviation 0.69
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Y Migration
|
0.24 Degrees
Standard Deviation 0.61
|
0.03 Degrees
Standard Deviation 0.44
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Z Migration
|
-0.01 Degrees
Standard Deviation 0.60
|
-0.31 Degrees
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: Patients will be examined at 60 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=19 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=20 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Rotations
Femoral X Rotation
|
0.35 Degrees
Standard Deviation 0.44
|
0.16 Degrees
Standard Deviation 0.54
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Y Rotation
|
0.29 Degrees
Standard Deviation 0.79
|
-0.34 Degrees
Standard Deviation 2.07
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Z Rotation
|
-0.17 Degrees
Standard Deviation 1.14
|
0.25 Degrees
Standard Deviation 0.88
|
|
Radiostereometric Analysis Examination - Rotations
Tibial X Rotation
|
-0.28 Degrees
Standard Deviation 0.80
|
-0.34 Degrees
Standard Deviation 1.19
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Y Rotation
|
0.28 Degrees
Standard Deviation 0.47
|
0.07 Degrees
Standard Deviation 0.40
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Z Rotation
|
-0.13 Degrees
Standard Deviation 0.68
|
-0.45 Degrees
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: Patients will be examined at 120 months post surgery.Population: 1 Cemented Oxford Unicompartmental Knee Arthroplasty could not be analysed due poor quality stereoradiographs with obstruction of bone markers being obstructed. Consequently, although 15 Cemented Oxford Unicompartmental Knee Arthroplasties were followed-up at 120 months, only 14 could be analysed.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component\* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component\* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=16 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=14 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Rotations
Femoral X Rotation
|
-0.02 Degrees
Standard Deviation 0.50
|
0.27 Degrees
Standard Deviation 0.55
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Y Rotation
|
0.19 Degrees
Standard Deviation 0.79
|
0.38 Degrees
Standard Deviation 0.81
|
|
Radiostereometric Analysis Examination - Rotations
Femoral Z Rotation
|
0.53 Degrees
Standard Deviation 0.90
|
0.38 Degrees
Standard Deviation 1.16
|
|
Radiostereometric Analysis Examination - Rotations
Tibial X Rotation
|
-0.43 Degrees
Standard Deviation 0.74
|
-0.66 Degrees
Standard Deviation 2.59
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Y Rotation
|
0.18 Degrees
Standard Deviation 0.48
|
0.15 Degrees
Standard Deviation 0.36
|
|
Radiostereometric Analysis Examination - Rotations
Tibial Z Rotation
|
-0.50 Degrees
Standard Deviation 0.64
|
-0.79 Degrees
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: Patients will be examined at 3 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Femoral MTPM
|
0.93 millimetres
Standard Deviation 0.67
|
0.80 millimetres
Standard Deviation 0.36
|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Tibial MTPM
|
0.84 millimetres
Standard Deviation 0.45
|
0.61 millimetres
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: Patients will be examined at 12 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Tibial MTPM
|
0.78 millimetres
Standard Deviation 0.37
|
0.65 millimetres
Standard Deviation 0.45
|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Femoral MTPM
|
0.76 millimetres
Standard Deviation 0.35
|
0.80 millimetres
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: Patients will be examined at 24 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Femoral MTPM
|
0.87 millimetres
Standard Deviation 0.42
|
0.94 millimetres
Standard Deviation 0.87
|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Tibial MTPM
|
0.84 millimetres
Standard Deviation 0.39
|
0.64 millimetres
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Patients will be examined at 60 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=19 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=20 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Femoral MTPM
|
0.87 millimetres
Standard Deviation 0.40
|
0.95 millimetres
Standard Deviation 0.88
|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Tibial MTPM
|
0.79 millimetres
Standard Deviation 0.30
|
0.80 millimetres
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: Patients will be examined at 120 months post surgery.Population: 1 Cemented Oxford Unicompartmental Knee Arthroplasty could not be analysed due poor quality stereoradiographs with obstruction of bone markers being obstructed. Consequently, although 15 Cemented Oxford Unicompartmental Knee Arthroplasties were followed-up at 120 months, only 14 could be analysed.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=16 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=14 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Femoral MTPM
|
0.98 millimetres
Standard Deviation 0.41
|
0.84 millimetres
Standard Deviation 0.41
|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Tibial MTPM
|
0.82 millimetres
Standard Deviation 0.32
|
0.95 millimetres
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: Patients will be examined at 12 months post surgery.Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiographic Examination
Tibial Component · Partial Radiolucency
|
7 Participants
|
11 Participants
|
|
Radiographic Examination
Tibial Component · Complete Radiolucency
|
1 Participants
|
2 Participants
|
|
Radiographic Examination
Tibial Component · No Radiolucency
|
14 Participants
|
8 Participants
|
|
Radiographic Examination
Femoral Component · Partial Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Femoral Component · Complete Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Femoral Component · No Radiolucency
|
22 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: Patients will be examined at 24 months post surgery.Population: Plain radiographs were only available for 21 of the 22 Cementless Oxford Unicompartmental Knee Arthroplasties at the 60 month timepoint, which explains the discrepency between the number of patients analyzed and the number of patients reported in the patient flow.
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiographic Examination
Femoral Component · No Radiolucency
|
21 Participants
|
21 Participants
|
|
Radiographic Examination
Tibial Component · Partial Radiolucency
|
6 Participants
|
8 Participants
|
|
Radiographic Examination
Tibial Component · Complate Radiolucency
|
0 Participants
|
5 Participants
|
|
Radiographic Examination
Tibial Component · No Radiolucency
|
15 Participants
|
8 Participants
|
|
Radiographic Examination
Femoral Component · Partial Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Femoral Component · Complate Radiolucency
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Patients will be examined at 60 months post surgery.Population: Plain radiographs were only available for 18 of the 20 Cemented Oxford Unicompartmental Knee Arthroplasties at the 60 month timepoint, which explains the discrepency between the number of patients analyzed and the number of patients reported in the patient flow.
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=19 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=18 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiographic Examination
Tibial Component · Partial Radiolucency
|
1 Participants
|
6 Participants
|
|
Radiographic Examination
Tibial Component · Complete Radiolucency
|
0 Participants
|
1 Participants
|
|
Radiographic Examination
Tibial Component · No Radiolucency
|
18 Participants
|
11 Participants
|
|
Radiographic Examination
Femoral Component · Partial Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Femoral Component · Complete Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Femoral Component · No Radiolucency
|
19 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Patients will be examined at 120 months post surgery.Population: Plain radiographs were only available for 15 of the 16 Cementless Oxford Unicompartmental Knee Arthroplasties and 14 of the 15 Cemented Oxford Unicompartmental Knee Arthroplastiesat the 60 month timepoint, which explains the discrepency between the number of patients analyzed and the number of patients reported in the patient flow.
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=15 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=14 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiographic Examination
Tibial Component · Partial Radiolucency
|
1 Participants
|
6 Participants
|
|
Radiographic Examination
Tibial Component · Complete Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Tibial Component · No Radiolucency
|
14 Participants
|
8 Participants
|
|
Radiographic Examination
Femoral Component · Partial Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Femoral Component · Complete Radiolucency
|
0 Participants
|
0 Participants
|
|
Radiographic Examination
Femoral Component · No Radiolucency
|
15 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Patients will be assessed pre-operatively.Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=23 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=24 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Clinical Assessment
|
24 score on a scale
Standard Deviation 7
|
23 score on a scale
Standard Deviation 6
|
PRIMARY outcome
Timeframe: Patients will be assessed at 12 months post surgery.Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Clinical Assessment
|
41 score on a scale
Interval 28.0 to 48.0
|
40 score on a scale
Interval 20.0 to 47.0
|
PRIMARY outcome
Timeframe: Patients will be assessed at 24 months post surgery.Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Clinical Assessment
|
42 score on a scale
Interval 24.0 to 48.0
|
38 score on a scale
Interval 20.0 to 47.0
|
PRIMARY outcome
Timeframe: Patients will be assessed at 60 months post surgery.Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=20 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=19 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Clinical Assessment
|
41 score on a scale
Standard Deviation 7
|
37 score on a scale
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Patients will be assessed at 120 months post surgery.Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=16 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=14 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Clinical Assessment
|
42 score on a scale
Standard Deviation 7
|
39 score on a scale
Standard Deviation 10
|
PRIMARY outcome
Timeframe: Patients will be assessed at 6 months post surgery.Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Outcome measures
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=22 Participants
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=21 Participants
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Femoral MTPM
|
0.86 millimetres
Standard Deviation 0.43
|
0.80 millimetres
Standard Deviation 0.44
|
|
Radiostereometric Analysis Examination - Maximum Total Point Motion
Tibial MTPM
|
0.79 millimetres
Standard Deviation 0.42
|
0.64 millimetres
Standard Deviation 0.45
|
Adverse Events
Cementless Oxford Unicompartmental Knee Arthroplasty
Cemented Oxford Unicompartmental Knee Arthroplasty
Serious adverse events
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=23 participants at risk
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=24 participants at risk
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Surgical and medical procedures
Implant Revision
|
4.3%
1/23 • Number of events 1 • Adverse event data was collected out to 10 years follow-up.
|
4.2%
1/24 • Number of events 1 • Adverse event data was collected out to 10 years follow-up.
|
Other adverse events
| Measure |
Cementless Oxford Unicompartmental Knee Arthroplasty
n=23 participants at risk
Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
|
Cemented Oxford Unicompartmental Knee Arthroplasty
n=24 participants at risk
Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.
|
|---|---|---|
|
Surgical and medical procedures
Mobile Bearing Dislocation
|
0.00%
0/23 • Adverse event data was collected out to 10 years follow-up.
|
4.2%
1/24 • Number of events 1 • Adverse event data was collected out to 10 years follow-up.
|
Additional Information
Professor David W Murray
University of Oxford, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place