Avascular Necrosis, Correction of Functional Deformity, Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Rheumatoid Arthritis
Conditions
Keywords
Total Hip Arthroplasty, Medical Device, Performance, Safety, Hip prosthesis, Roentgen Stereophotogrammetric Analysis
Brief summary
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
Detailed description
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner. All potential study subjects will be required to participate in the Informed Consent process.
Interventions
DEVICETaperloc Complete Microplasty stem
Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
DEVICETaperloc Complete Reduced Distal stem
Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 assignment of treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis. * Correction of functional deformity. * Male or female -≥ 18 and ≤ 70 years of age * Subjects willing to return for follow-up evaluations. * Subjects able to read and understand Dutch language.
Exclusion criteria
* active Infection (or within 6 weeks after infection) * Sepsis * Osteomyelitis * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * diagnosed Osteoporosis or Osteomalacia * Metabolic disorders which may impair bone formation * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy or neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) | 2 years postoperatively | Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | 2 years postoperatively | Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation. |
| Early Survival Assessed by Counting the Number of Implant Revisions | Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively | Assessed by counting the number of implant revisions |
| Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively | Harris 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) |
| Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | 2 years postoperatively | The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms. |
| Clinical Performance Measured by Patient Based Outcome EQ5D | 2 years postoperatively | Each 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). |
| Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively | 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. |
| Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | 6 weeks, 1 year and 2 years postoperatively | 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. |
| Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | 6 weeks, 1 year and 2 years postoperatively | Assess radiographs for signs of stress shielding, radiolucency and stem alignment. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 21 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 3 |
Baseline characteristics
| Characteristic | Taperloc Complete Microplasty Stem | Taperloc Complete Reduced Distal Stem | Total |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 6.3 | 63.9 years STANDARD_DEVIATION 6.5 | 63.7 years STANDARD_DEVIATION 6.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 21 |
| other Total, other adverse events | 2 / 25 | 9 / 21 |
| serious Total, serious adverse events | 2 / 25 | 0 / 21 |
Outcome results
Primary
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)
Time frame: 2 years postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taperloc Complete Microplasty Stem | Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) | 3.15 mm | Standard Deviation 2.4 |
| Taperloc Complete Reduced Distal Stem | Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) | 3.90 mm | Standard Deviation 4.17 |
Secondary
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Assess radiographs for signs of stress shielding, radiolucency and stem alignment.
Time frame: 6 weeks, 1 year and 2 years postoperatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | Stress shielding | 0 Participants |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | Radiolucency | 0 Participants |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | stem alignment (between <5 valgus and <5 varus) | 25 Participants |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | Stress shielding | 0 Participants |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | Radiolucency | 0 Participants |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | stem alignment (between <5 valgus and <5 varus) | 21 Participants |
Secondary
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
Harris 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)
Time frame: pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | pre-op | 63.9 scores on a scale | Standard Deviation 7.7 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | 6 week | 79.9 scores on a scale | Standard Deviation 11.4 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | 1 year | 96.7 scores on a scale | Standard Deviation 4.6 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | 2 year | 98.3 scores on a scale | Standard Deviation 3.1 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | 2 year | 97.6 scores on a scale | Standard Deviation 4.9 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | pre-op | 65.1 scores on a scale | Standard Deviation 13.9 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | 1 year | 95.7 scores on a scale | Standard Deviation 5.9 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | 6 week | 82.4 scores on a scale | Standard Deviation 8.8 |
Secondary
Clinical Performance Measured by Patient Based Outcome EQ5D
Each 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).
Time frame: 2 years postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome EQ5D | EQ-5D | 0.9 score on a scale | Standard Error 0.1 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome EQ5D | Health status | 81.0 score on a scale | Standard Error 12.3 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome EQ5D | EQ-5D | 0.9 score on a scale | Standard Error 0.1 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome EQ5D | Health status | 81.0 score on a scale | Standard Error 15.6 |
Secondary
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
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.
Time frame: 6 weeks, 1 year and 2 years postoperatively
Population: Number of analyzed patients differs between the time points due to missing values
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | 6 week | 47.8 score on a scale | Standard Deviation 30 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | 1 year | 69.9 score on a scale | Standard Deviation 29.2 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | 2 year | 72.3 score on a scale | Standard Deviation 30.5 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | 6 week | 43.2 score on a scale | Standard Deviation 26.1 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | 1 year | 61.7 score on a scale | Standard Deviation 29.6 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | 2 year | 80.3 score on a scale | Standard Deviation 26.5 |
Secondary
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.
Time frame: 2 years postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taperloc Complete Microplasty Stem | 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 |
| Taperloc Complete Microplasty Stem | 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 |
| Taperloc Complete Microplasty Stem | 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 |
| Taperloc Complete Microplasty Stem | 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 |
| Taperloc Complete Microplasty Stem | 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 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | Quality of life | 84.4 scores on a scale | Standard Deviation 17 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | Pain | 92 scores on a scale | Standard Deviation 9.2 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | Symptoms | 85.5 scores on a scale | Standard Deviation 13.3 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | Activity limitations daily living | 90.8 scores on a scale | Standard Deviation 10.1 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | Sport/Recreation | 79.6 scores on a scale | Standard Deviation 20.2 |
Secondary
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
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.
Time frame: pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Population: Number of analyzed patients differs between the time points due to missing values
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | pre-op | 26.1 scores on a scale | Standard Deviation 7.6 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | 6 week | 38.3 scores on a scale | Standard Deviation 6.7 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | 1 year | 44.6 scores on a scale | Standard Deviation 3.4 |
| Taperloc Complete Microplasty Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | 2 year | 45.7 scores on a scale | Standard Deviation 3.8 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | 2 year | 44.9 scores on a scale | Standard Deviation 3.6 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | pre-op | 25.6 scores on a scale | Standard Deviation 8.5 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | 1 year | 43.1 scores on a scale | Standard Deviation 4.1 |
| Taperloc Complete Reduced Distal Stem | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | 6 week | 37.5 scores on a scale | Standard Deviation 4.8 |
Secondary
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.
Time frame: 2 years postoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Taperloc Complete Microplasty Stem | Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Stem malalignment | 0 participants |
| Taperloc Complete Microplasty Stem | Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Incorrect sizing | 0 participants |
| Taperloc Complete Microplasty Stem | Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Subsidence | 2 participants |
| Taperloc Complete Reduced Distal Stem | Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Stem malalignment | 0 participants |
| Taperloc Complete Reduced Distal Stem | Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Incorrect sizing | 0 participants |
| Taperloc Complete Reduced Distal Stem | Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Subsidence | 6 participants |
Secondary
Early Survival Assessed by Counting the Number of Implant Revisions
Assessed by counting the number of implant revisions
Time frame: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Taperloc Complete Microplasty Stem | Early Survival Assessed by Counting the Number of Implant Revisions | 0 implant revisions |
| Taperloc Complete Reduced Distal Stem | Early Survival Assessed by Counting the Number of Implant Revisions | 0 implant revisions |