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MDR - PMCF Study for Taperloc Complete Stems

NCT04028687 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 820

Last updated 2025-03-11

No results posted yet for this study

Summary

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

Conditions

  • Hip Arthritis
  • Hip Disease
  • Hip Fractures
  • Hip Injuries
  • Hip Pain Chronic

Interventions

DEVICE

Taperloc Complete Stem

Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2032-02-12
Completion
2032-02-12
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04028687 on ClinicalTrials.gov