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REDAPT Retrospective-Prospective Modular Stem Study

NCT02661620 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-04-02

No results posted yet for this study

Summary

A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. The study will collect retrospective data from medical records review and prospective data from observations data at 5 and 10 postoperatively clinical visits. There will also be a 7.5 year telephone follow up contact to assess for device status and adverse events.

Conditions

  • Arthroplasties, Hip Replacement

Interventions

DEVICE

REDAPT Revision Femoral System modular stem

Medical record review for retrospective information and observational prospective data collection of standard of care items at 5 years and 10 years post operatively plus a 7.5 year post op telephone call to assess stem status and adverse events.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Rachel Jahnke · Smith & Nephew, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-04-16
Completion
2020-04-16

Countries

  • United States
  • Belgium
  • Canada

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 NCT02661620 on ClinicalTrials.gov