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

NCT03681639 | Completed Results

• 1 other identifier: 09-H00
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hip resurfacing; Medical Device; Safety; Hip prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Harris Hip Score

  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)

  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

  Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery

• Radiographic Evaluation

  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)

  Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery

Study Arms (1)

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.

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

Interventions

Serum Metal ion levels determined to monitor changes in chromium and cobalt levels DIAGNOSTIC_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.

Patients who received Metasul Monoblock in hip resurfacing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The study devices were taken off the market in 2013.

Results Point of Contact

• Title: Esther Foo
• Organization: Zimmer Biomet

esther.foo@zimmerbiomet.com

+41792894930

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 24, 2018
• Study Start: August 1, 2009
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-10

Locations

DE (1)