Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681639
Other study ID # 09-H00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2009
Est. completion date August 21, 2023

Study information

Verified date August 2023
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date August 21, 2023
Est. primary completion date February 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
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.

Locations

Country Name City State
Germany Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden Dresden

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Primary Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method 10 years post-surgery
Secondary 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).
10 years post-surgery
Secondary 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. 10 years post-surgery
Secondary 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." 10 years post-surgery
Secondary Safety based on eventual complications occurred including dislocations and revisions/removals 10 years post-surgery
Secondary X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc 10 years post-surgery
Secondary 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. 5 years post-surgery
Secondary 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. 5 years post-surgery
Secondary 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. 5 years post-surgery
Secondary 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. 5 years post-surgery
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4