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

Zimmer Biomet45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Serum Metal ion levels determined to monitor changes in chromium and cobalt levelsDIAGNOSTIC_TEST

Analyses was performed pre-operatively, 6 months, 1 year, 2 years and 5 years post-operatively 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 was analysed by an approved Central Laboratory. The Central Laboratory provided specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory provided the results to the Investigators. The cobalt and chromium was measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient selection without bias to race or gender. 2. Patient is ≥ 18 and ≤ 65 years of age. 3. Female patients only, if 1. Actively practicing a contraceptive method, or 2. Surgically sterilized, or 3. Post-menopausal 4. Pre-operative Harris Hip Score ≤ 70. 5. 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: 1. Non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis 2. Inflammatory joint disease (IJD), e.g., rheumatoid arthritis 6. Patient is willing and able to cooperate in prescribed post-operative therapy. 7. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. 8. Patient has participated in the Informed Consent process and has signed an Ethics Committee approved Informed Consent. Exclusion Criteria: 1. Patient has an acute, chronic, local or systemic infection. 2. Patient is skeletally immature. 3. Patient is known to be pregnant. 4. Patient has a severe muscular, neural or vascular disease that endangers the involved extremity. 5. 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: 1. patient with severe osteopenia, 2. patients with a family history of severe osteoporosis or osteopenia, 3. patients with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT grade), or 4. patients with local bone tumors and/or cysts of the femoral head \> 1 cm 6. Patient has a total or partial absence of the muscular or ligamentous apparatus. 7. Patient has known moderate to severe renal insufficiency. 8. Patient has a known clinical condition which may interfere with the patient's outcome, including but not limited to: 1. immunocompromised conditions (AIDS), 2. organ transplant, 3. high doses of corticosteroids etc 9. Patient is severely overweight (BMI \> 40) 10. Patient is scheduled for simultaneous bilateral total hip replacement. 11. OPERATIVE (IPSILATERAL) HIP: Patient has a total prosthetic hip replacement device, surface arthroplasty, endoprosthesis or femoral and/or acetabular osteosynthesis. 12. CONTRALATERAL HIP: Patient has had a hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless previously enrolled in this clinical study. 13. Patient is: 1. a prisoner, 2. mentally incompetent, 3. a known alcohol or drug abuser, 4. anticipated to be non-compliant 14. 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. 15. Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.

Locations (1)

Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden

Dresden, Germany

Outcomes

Primary Outcomes

Implant Survival

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.

Time frame: 10 years post-surgery

Secondary Outcomes

Harris Hip Score

The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain, function and functional activities, absence of deformity and range of motion. The total score vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.

Time frame: 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)

The SF-12 is a multi-purpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.

Time frame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery

Patient's Activity Level Determined by UCLA Score

The UCLA score was a part of the Patient Activity Questionnaire which ascertains the patient's activity level from 1 (low) to 10 (high) in patients undergoing total hip arthroplasty.

Time frame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery

Data from ClinicalTrials.gov

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