Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Conditions
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Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity, Rheumatoid Arthritis

Intervention / Treatment
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* Device: Taperloc Complete Microplasty stem
* Device: Taperloc Complete Reduced Distal stem


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 assignment of treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taperloc Complete Microplasty stem<br>Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem. | Device: Taperloc Complete Microplasty stem<br>* Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner<br>* Other names: Total hip arthroplasty;|
| Active Comparator: Taperloc Complete Reduced Distal stem<br>Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem. | Device: Taperloc Complete Reduced Distal stem<br>* Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner<br>* Other names: Total hip arthroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years postoperatively | 
| Early Survival Assessed by Counting the Number of Implant Revisions | Assessed by counting the number of implant revisions | Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively | 
| 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) | pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively | 
| Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | Assess radiographs for signs of stress shielding, radiolucency and stem alignment. | 6 weeks, 1 year and 2 years postoperatively | 
| 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. | 2 years postoperatively | 
| 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). | 2 years postoperatively | 
| 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. | pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively | 
| 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. | 6 weeks, 1 year and 2 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Device, Total Hip Arthroplasty, Performance, Safety, Hip prosthesis, Roentgen Stereophotogrammetric Analysis