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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681639
• Other study ID #: 09-H00
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis of Hip
• Inflammatory Arthritis
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis

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