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

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.

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Inflammatory Arthritis; Osteoarthritis, Hip; Avascular Necrosis of Hip; Post-traumatic; Arthrosis
• Intervention / Treatment: Diagnostic test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients who received Metasul Monoblock in hip resurfacing; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Radiographic Evaluation	Radiographic parameters evaluated were radiolucencies, osteolysis, hypertrophy, subsidence, cup migration, change in cup angle and change in femoral shaft angle. The radiographs related to any significant radiographic findings reported by an Investigator were also be assessed by an Independent Radiographic Reviewer. The data presented in the outcome measure data table represent the Number of Participants with Abnormal or Significant Findings during the course of the study.	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)	The EuroQol 5 Dimension (EQ-5D) is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, selfcare, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. For this study, the VAS score was not calculated.	Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Oxford Hip Score	The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. Scores ranges from 0 to 100 and the outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27.	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)	The WOMAC Score is a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip. These set of standardized questions are used by doctors to evaluate the condition of osteoarthritis patients. The WOMAC score was an optional form reported for pain and physical function. The test questions are scored on a scale of 0-4, which correspond to: No pain (0), Mild pain (1), Moderate pain (2), Severe pain (3), and Extreme pain (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain (with higher values representing worse outcomes and lower values representing better outcomes) and 0-68 for Physical Function (with higher values representing better outcomes and lower values representing worse outcomes).	Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject quality-of-life determined by the EQ-5D (EuroQoI) score	Optional: EQ-5D is a standardized instrument for measuring health status. It is made up for two components. The description part: health status is measured in five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself. Usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have. In anxiety/depression dimension, it asks how anxious or depressed they are. Visual analogue scale: The patient marks his health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. The bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".	10 years post-surgery
Pain and functional performance based on the Oxford Patient Questionnaire	Optional: the Oxford Hip Score Form consists of 12 questions relative to the function and pain associated of the hip and completed by the patient.	10 years post-surgery
Pain and functional performance based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Optional: the WOMAC Score is a patient completed questionnaire developed to assess pain and functional ability in patients suffering from osteoporosis.	10 years post-surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2009
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Hip resurfacing; Medical Device; Hip prosthesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Rheumatic Diseases; Arthritis; Necrosis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Trace Elements; Micronutrients; Cobalt; Chromium
• Other Study ID Numbers: 09-H00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No