Avascular Necrosis of HipMMCNCT03681639
Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
A study testing Serum Metal ion levels determined to monitor changes in chromium and cobalt levels in people with Avascular Necrosis of Hip and Osteoarthritis, Hip, run by Zimmer Biomet at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis
- What is being tested?
- Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2009to 22 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden
Dresden, 01307
About this study
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.
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.
Read the 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.
- Conditions
- Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Post-traumatic; Arthrosis
- Being tested
- Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
- Keywords
- Hip resurfacing, Medical Device, Safety, Hip prosthesis
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Rheumatoid, Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received Metasul Monoblock in hip resurfacing | Experimental | 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. Receives: Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years post-surgery
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Aug 2009
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Avascular Necrosis of HipStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681639
- Sponsor's protocol ID
- 09-H00
- Acronym
- MMC
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2018
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03681639
- Acronym / sponsor ID
- MMC / 09-H00
- Conditions
- Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Post-traumatic; Arthrosis
- Keywords
- Hip resurfacing, Medical Device, Safety, Hip prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2009 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received Metasul Monoblock in hip resurfacing | Experimental | Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levelsPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient selection without bias to race or gender.
- Patient is ≥ 18 and ≤ 65 years of age.
- Female patients only, if
- 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:
Key exclusion criteria (26 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Metal ion levels determined to monitor changes in chromium and cobalt levelsAnalyses 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. | Diagnostic test | Patients who received Metasul Monoblock in hip resurfacing |
Primary outcome
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.
7 secondary outcomes
Harris Hip Score
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)
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
Time frame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Radiographic Evaluation
Time frame: 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)
Time frame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Oxford Hip Score
Time frame: 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)
Time frame: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Achakri study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum Metal ion levels determined to monitor changes in chromium and cobalt levels in people with Avascular Necrosis of Hip and Osteoarthritis, Hip, run by Zimmer Biomet at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survival (time frame: 10 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.