Trial Outcomes & Findings for Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty. (NCT NCT03409666)
NCT ID: NCT03409666
Last Updated: 2022-07-14
Results Overview
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
2 years postoperatively
Results posted on
2022-07-14
Participant Flow
Participant milestones
| Measure |
Taperloc Complete Microplasty Stem
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Taperloc Complete Microplasty Stem
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
Baseline characteristics by cohort
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 6.3 • n=25 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
63.9 years
STANDARD_DEVIATION 6.5 • n=21 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
63.7 years
STANDARD_DEVIATION 6.4 • n=46 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
|
Sex: Female, Male
Female
|
20 Participants
n=25 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
15 Participants
n=21 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
35 Participants
n=46 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
|
Sex: Female, Male
Male
|
5 Participants
n=25 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
6 Participants
n=21 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
11 Participants
n=46 Participants • These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 2 years postoperativelyPopulation: RSA data from 35 patients (20 Taperloc Complete Reduced Distal \& 15 Taperloc Complete Microplasty) is available for the comparison of migration between the investigated stems.
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=15 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=20 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
|
3.15 mm
Standard Deviation 2.40
|
3.90 mm
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: 2 years postoperativelyAssessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Stem malalignment
|
0 participants
|
0 participants
|
|
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Incorrect sizing
|
0 participants
|
0 participants
|
|
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Subsidence
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperativelyAssessed by counting the number of implant revisions
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Early Survival Assessed by Counting the Number of Implant Revisions
|
0 implant revisions
|
0 implant revisions
|
SECONDARY outcome
Timeframe: pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperativelyHarris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
pre-op
|
63.9 scores on a scale
Standard Deviation 7.7
|
65.1 scores on a scale
Standard Deviation 13.9
|
|
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
6 week
|
79.9 scores on a scale
Standard Deviation 11.4
|
82.4 scores on a scale
Standard Deviation 8.8
|
|
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
1 year
|
96.7 scores on a scale
Standard Deviation 4.6
|
95.7 scores on a scale
Standard Deviation 5.9
|
|
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
2 year
|
98.3 scores on a scale
Standard Deviation 3.1
|
97.6 scores on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 6 weeks, 1 year and 2 years postoperativelyAssess radiographs for signs of stress shielding, radiolucency and stem alignment.
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
stem alignment (between <5 valgus and <5 varus)
|
25 Participants
|
21 Participants
|
|
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Stress shielding
|
0 Participants
|
0 Participants
|
|
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Radiolucency
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 years postoperativelyThe outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
Pain
|
94.2 scores on a scale
Standard Deviation 10.5
|
92 scores on a scale
Standard Deviation 9.2
|
|
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
Symptoms
|
89.8 scores on a scale
Standard Deviation 12
|
85.5 scores on a scale
Standard Deviation 13.3
|
|
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
Activity limitations daily living
|
92.7 scores on a scale
Standard Deviation 11.4
|
90.8 scores on a scale
Standard Deviation 10.1
|
|
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
Sport/Recreation
|
80.7 scores on a scale
Standard Deviation 24.1
|
79.6 scores on a scale
Standard Deviation 20.2
|
|
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
Quality of life
|
89.7 scores on a scale
Standard Deviation 16.8
|
84.4 scores on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 2 years postoperativelyEach question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=24 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=20 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Clinical Performance Measured by Patient Based Outcome EQ5D
EQ-5D
|
0.9 score on a scale
Standard Error 0.1
|
0.9 score on a scale
Standard Error 0.1
|
|
Clinical Performance Measured by Patient Based Outcome EQ5D
Health status
|
81.0 score on a scale
Standard Error 12.3
|
81.0 score on a scale
Standard Error 15.6
|
SECONDARY outcome
Timeframe: pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperativelyPopulation: Number of analyzed patients differs between the time points due to missing values
The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
pre-op
|
26.1 scores on a scale
Standard Deviation 7.6
|
25.6 scores on a scale
Standard Deviation 8.5
|
|
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
6 week
|
38.3 scores on a scale
Standard Deviation 6.7
|
37.5 scores on a scale
Standard Deviation 4.8
|
|
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
1 year
|
44.6 scores on a scale
Standard Deviation 3.4
|
43.1 scores on a scale
Standard Deviation 4.1
|
|
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
2 year
|
45.7 scores on a scale
Standard Deviation 3.8
|
44.9 scores on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 6 weeks, 1 year and 2 years postoperativelyPopulation: Number of analyzed patients differs between the time points due to missing values
The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.
Outcome measures
| Measure |
Taperloc Complete Microplasty Stem
n=25 Participants
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 Participants
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
6 week
|
47.8 score on a scale
Standard Deviation 30
|
43.2 score on a scale
Standard Deviation 26.1
|
|
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
1 year
|
69.9 score on a scale
Standard Deviation 29.2
|
61.7 score on a scale
Standard Deviation 29.6
|
|
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
2 year
|
72.3 score on a scale
Standard Deviation 30.5
|
80.3 score on a scale
Standard Deviation 26.5
|
Adverse Events
Taperloc Complete Microplasty Stem
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Taperloc Complete Reduced Distal Stem
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Taperloc Complete Microplasty Stem
n=25 participants at risk
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 participants at risk
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
General disorders
Fever
|
4.0%
1/25 • 2 years
|
0.00%
0/21 • 2 years
|
|
Cardiac disorders
hypotension
|
4.0%
1/25 • 2 years
|
0.00%
0/21 • 2 years
|
Other adverse events
| Measure |
Taperloc Complete Microplasty Stem
n=25 participants at risk
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
|
Taperloc Complete Reduced Distal Stem
n=21 participants at risk
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Stem Subsidence
|
8.0%
2/25 • 2 years
|
28.6%
6/21 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Periarticular Ossification
|
0.00%
0/25 • 2 years
|
4.8%
1/21 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pedestal Sign
|
0.00%
0/25 • 2 years
|
9.5%
2/21 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60