REDAPT Retrospective-Prospective Modular Stem Study

Stopped early

Conditions studied: Arthroplasties, Hip Replacement

In brief

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.

Key facts

Study ID

NCT02661620

Run by

Smith & Nephew, Inc.

People needed

140

Starts

2016-02-01

Expected to finish

2020-04-16

Last updated by the study team

2024-04-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Retrospective Limited Data Collection/Enrollment Phase:
• Subject has undergone revision hip arthroplasty with the REDAPT™ Revision Femoral System modular stem with implantation from 2012 to the date of Institutional Review Board (IRB)/Ethics Committee (EC) approval ofthe original version 1.0 protocol at the study site.
• Retrospective Expanded Data Collection \& Prospective Follow-Up Phase:
• Subject completed limited retrospective data collection phase and willing to consent to expanded retrospective data collection and the prospective phase of the study;
• Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
• Exclusion Criteria:Retrospective Limited Data Collection/Enrollment Phase:
• Not applicable
• Retrospective Expanded Data Collection \& Prospective Follow-Up Phase:
• Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse; or
• Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.

Where it is running

• Baptist Health Louisville Orthopedic — Louisville, Kentucky, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• The Oregon Health & Science University — Portland, Oregon, United States
• ZNA Campus Middelheim, Antwerpe — Antwerp, Belgium
• CHU De Quebec- Hôpital Saint-François d'Assise — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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