Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Post-traumatic; Arthrosis

Intervention / Treatment
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* Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels


Participation Criteria
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Eligibility Criteria
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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 ≤ 70. 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 Patient is willing and able to cooperate in prescribed post-operative therapy. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. Patient has participated in the Informed Consent process and has signed an Ethics Committee approved Informed Consent. 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. Patient has known moderate to severe renal insufficiency. Patient has a known clinical condition which may interfere with the patient's outcome, including but not limited to: immunocompromised conditions (AIDS), organ transplant, high doses of corticosteroids etc Patient is severely overweight (BMI > 40) Patient is scheduled for simultaneous bilateral total hip replacement. OPERATIVE (IPSILATERAL) HIP: Patient has a total prosthetic hip replacement device, surface arthroplasty, endoprosthesis or femoral and/or acetabular osteosynthesis. CONTRALATERAL HIP: Patient has had a hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless previously enrolled in this clinical study. Patient is: a prisoner, mentally incompetent, a known alcohol or drug abuser, anticipated to be non-compliant Patient has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Zimmer Hip Resurfacing clinical study. Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who received Metasul Monoblock in hip resurfacing<br>Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application with the Durom® Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured. | Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels<br>* Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul® LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method |  | 10 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and functional performance based on the Harris Hip Score | The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. 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). | 10 years post-surgery | 
| Subject quality-of-life determined by the SF-12 questionnaire | The SF-12 Questionnaire (form 7) is a 12-item questionnaire in accordance with the quality of life questioning standards of the American Academy of Orthopaedic Surgeons (AAOS) Committee for Outcomes Research. The questions determine the patient's physical, emotional and social health and will be used to calculate a physical and mental functional score. | 10 years post-surgery | 
| Patient's activity level determined by UCLA Score | The University of California at Los Angeles (UCLA) Score surveys a patient's hip and knee pain and function on a 10-point scale from a 1 - wholly inactive: dependent upon others; cannot leave residence, to a 5 - sometimes participate in moderate activities, to a 10 - regularly participate in impact sports, such as jogging, tennis, skiing, acrobatics, ballet, heavy labor, or backpacking. | 10 years post-surgery | 
| Safety based on eventual complications occurred including dislocations and revisions/removals |  | 10 years post-surgery | 
| X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc |  | 10 years post-surgery | 
| Metal ion (whole blood cobalt and chromium) determined by blood analysis | Metal ion levels (cobalt and chromium) content will be evaluated for all study subjects enrolled in this study. To prevent intra-observer variation, an approved Central Laboratory will provide specimen collection kits for the transfer of blood specimens and will analysed the metal ion concentrations. The cobalt and chromium contents will be measured by induced coupled plasma mass spectrometry (ICP-MS). The Blood Analysis Form will then be completed by the Investigator or his/her designee from the results of the blood analysis. | 5 years post-surgery | 
| Renal function (BUN) determined by blood analysis | Renal function (BUN) will be evaluated for all study subjects enrolled in this study. Phlebotomy (blood drawing), and evaluation of BUN content will be conducted locally. The Blood Analysis Form will then be completed by the Investigator or his/her designee from the results of the blood analysis. | 5 years post-surgery | 
| Renal function (Creatinine) determined by blood analysis | Renal function (Creatinine) will be evaluated for all study subjects enrolled in this study. Phlebotomy (blood drawing), and evaluation of Creatinine content will be conducted locally. The Blood Analysis Form will then be completed by the Investigator or his/her designee from the results of the blood analysis. | 5 years post-surgery | 
| Renal function (GFR) determined by blood analysis | Renal function (GFR) will be evaluated for all study subjects enrolled in this study. Phlebotomy (blood drawing), and evaluation of GFR content will be conducted locally. The Blood Analysis Form will then be completed by the Investigator or his/her designee from the results of the blood analysis. | 5 years post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip resurfacing, Medical Device, Safety, Hip prosthesis