Back to resultsMetasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
Primary Purpose
Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
Sponsored by
About this trial
This is an interventional treatment trial for Avascular Necrosis of Hip focused on measuring Hip resurfacing, Medical Device, Safety, Hip prosthesis
Eligibility Criteria
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.
Sites / Locations
- Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients who received Metasul Monoblock in hip resurfacing
Arm Description
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.
Outcomes
Primary Outcome Measures
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Secondary Outcome Measures
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).
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.
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."
Safety based on eventual complications occurred including dislocations and revisions/removals
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03681639
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2009 (Actual)
Primary Completion Date
February 22, 2023 (Actual)
Study Completion Date
August 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Post-traumatic; Arthrosis
Keywords
Hip resurfacing, Medical Device, Safety, Hip prosthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients who received Metasul Monoblock in hip resurfacing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
Intervention Description
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.
Primary Outcome Measure Information:
Title
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time Frame
10 years post-surgery
Secondary Outcome Measure Information:
Title
Pain and functional performance based on the Harris Hip Score
Description
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).
Time Frame
10 years post-surgery
Title
Subject quality-of-life determined by the SF-12 questionnaire
Description
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.
Time Frame
10 years post-surgery
Title
Patient's activity level determined by UCLA Score
Description
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."
Time Frame
10 years post-surgery
Title
Safety based on eventual complications occurred including dislocations and revisions/removals
Time Frame
10 years post-surgery
Title
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Time Frame
10 years post-surgery
Title
Metal ion (whole blood cobalt and chromium) determined by blood analysis
Description
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.
Time Frame
5 years post-surgery
Title
Renal function (BUN) determined by blood analysis
Description
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.
Time Frame
5 years post-surgery
Title
Renal function (Creatinine) determined by blood analysis
Description
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.
Time Frame
5 years post-surgery
Title
Renal function (GFR) determined by blood analysis
Description
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.
Time Frame
5 years post-surgery
Other Pre-specified Outcome Measures:
Title
Subject quality-of-life determined by the EQ-5D (EuroQoI) score
Description
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".
Time Frame
10 years post-surgery
Title
Pain and functional performance based on the Oxford Patient Questionnaire
Description
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.
Time Frame
10 years post-surgery
Title
Pain and functional performance based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
Optional: the WOMAC Score is a patient completed questionnaire developed to assess pain and functional ability in patients suffering from osteoporosis.
Time Frame
10 years post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Vivoda
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
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