Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

Study Overview
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Brief Summary
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The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.

Official Title
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A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group

Conditions
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Arthritis, Degenerative

Intervention / Treatment
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* Device: ODH Hip System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years old Skeletally mature Requires primary, unilateral total hip arthroplasty due to degenerative join disease Preoperative Harris Hip Score of less than or equal to 70 Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk Given consent to participate in the study Able to understand the purpose of the study, his/her role, and is available for follow-up 10 year extension: Subject has completed the 2 year primary study Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up Exclusion Criteria: Diagnosis with high risk of Total Hip Arthroplasty (THA) failure Requires bilateral THA Requires revision of a prior hip replacement Active infection or sepsis History of local hip infection Known metastatic or neoplastic disease Conditions that may interfere with THA survival or outcomes Need for structural bone grafts to support the implant Contralateral lower extremity condition Has other joint replacements or plans for other joint replacements within 2 years Systemic steroid therapy within 3 months prior to surgery Life expectancy less than 2 years Intra-articular therapy within 6 months of enrollment Female of child-bearing age not using contraception Inadequate bone stock to support the device Moderate to severe renal insufficiency Emotional or neurological condition that would pre-empt ability or willingness to participate in the study BMI >40 Above the knee amputation of the contralateral or ipsilateral leg Known allergies to the components of the devices Entered into another investigational study Is a prisoner 10 year extension: • In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.

Ages Eligible for Study
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Minimum Age: 21 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Total Hip Replacement Device<br>Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes: R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem OXINIUM heads on polyethylene liners or Ceramic heads on ceramic liners (all uncemented components) | Device: ODH Hip System<br> <br> * Other names: THA;|
| Experimental: Investigational Hard-on-Hard Total Hip Replacement Device<br>Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes: R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm) R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm) Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8) | Device: ODH Hip System<br> <br> * Other names: THA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision Rate | Reoperations that led to removal or replacement of any of the acetabular or femoral components. | Up to 10 Years | 
| Adverse Events |  | Up to 10 Years | 
| Metal Ion Concentration in Whole Blood |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip score |  | Up to 10 years | 
| Hip Disability and Osteoarthritis Outcome Scores (HOOS) |  | Up to 10 years | 
| Radiographic measures | Assessment of bone loss, radiolucencies, subsidence, and heterotopic ossification | Up to 10 years | 
| Health economic outcomes-Surgical blood loss | Measured in ml blood | Intra-operative | 
| Health economic outcomes -Length of hospital stay | Measure of days spent in hospital | Hospital admission to discharge | 
| Health economic outcomes-Operative time | Operative time - first incision into skin to time when last suture is applied | Intra-operative | 
| Health economic outcomes - Re-hospitalisations | Re-hospitalisations-number of re-admissions to hospital | Up to 10 years |