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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

Patients will be examined 3 months post surgery.

Results posted on

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Cemented Oxford Unicompartmental Knee Arthroplasty

Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths

Serious adverse events

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

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

Phone: +44 01865 27457

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place