A Multi-Centre, Prospective Study to Obtain Survival and Clinical Outcome Data on the Zimmer Hip Resurfacing System Utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Avascular Necrosis of Hip
- Sponsor
- Zimmer Biomet
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Implant Survival
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
Detailed Description
This is a multi-center, prospective, non-controlled post market surveillance study. The objective of this study is to obtain survival and outcome data on the Zimmer Hip Resurfacing System. This will be assessed by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy of the Zimmer Hip Resurfacing System. Serum metal ion levels (cobalt and chromium) will also be collected pre-operatively and again at 6 months, 1 year, 2 years and 5 years. This procedure will offer an option to these patients who would otherwise require and likely outlive a conventional total hip replacement.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient selection without bias to race or gender.
- •Patient is ≥ 18 and ≤ 65 years of age.
- •Female patients only, if
- •Actively practicing a contraceptive method, or
- •Surgically sterilized, or
- •Post-menopausal
- •Pre-operative Harris Hip Score ≤
- •Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, which may include the following diagnosis:
- •Non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis
- •Inflammatory joint disease (IJD), e.g., rheumatoid arthritis
Exclusion Criteria
- •Patient has an acute, chronic, local or systemic infection.
- •Patient is skeletally immature.
- •Patient is known to be pregnant.
- •Patient has a severe muscular, neural or vascular disease that endangers the involved extremity.
- •Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including, but not limited to:
- •patient with severe osteopenia,
- •patients with a family history of severe osteoporosis or osteopenia,
- •patients with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT grade), or
- •patients with local bone tumors and/or cysts of the femoral head \> 1 cm
- •Patient has a total or partial absence of the muscular or ligamentous apparatus.
Outcomes
Primary Outcomes
Implant Survival
Time Frame: 10 years post-surgery
The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Metasul Monoblock Component Cup calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
Secondary Outcomes
- Patient's Activity Level Determined by UCLA Score(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Harris Hip Score(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Radiographic Evaluation(Pre-op, 6 weeks, 1,2,3,5,7 and 10 years post operatively 2, 3, 5, 7 and 10 years post-operatively. 2, 3, 5, 7 and 10 years post-operatively.)
- EuroQol 5 Dimension (EQ-5D)(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Oxford Hip Score(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)