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

NCT03681639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-12-03

Study results available
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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

Interventions

DIAGNOSTIC_TEST

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

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hassan Achakri · Zimmer Biomet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-01
Primary Completion
2023-05-22
Completion
2023-05-22

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03681639 on ClinicalTrials.gov