CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Serum Metal ion levels determined to monitor changes in chromium and cobalt levelsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03681639
NCT03681639N/ACompleted

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.

Zimmer Biomet·interventional·Posted Sep 24, 2018·Updated Dec 3, 2024

In Brief

A clinical study evaluating Serum Metal ion levels determined to monitor changes in chromium and cobalt levels for Avascular Necrosis of Hip and 4 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 24, 2018
Enrollment StartAug 1, 2009
Primary CompletionMay 22, 2023
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 7.8 years ago

Interventions

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

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.