Clinical trial NCT03681639: Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avascular Necrosis of Hip
Osteoarthritis, Hip
Rheumatoid Arthritis
Inflammatory Arthritis
Post-traumatic; Arthrosis
Keywords: Hip resurfacing
Medical Device
Safety
Hip prosthesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-09-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant Survival
timeFrame: 10 years post-surgery
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
measure: Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
timeFrame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
measure: Patient's Activity Level Determined by UCLA Score
timeFrame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
measure: Radiographic Evaluation
timeFrame: 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.
measure: EuroQol 5 Dimension (EQ-5D)
timeFrame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
measure: Oxford Hip Score
timeFrame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
measure: Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: