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Arthroplasties, Hip Replacement

REDAPT Retrospective-Prospective Modular Stem Study

Sponsored by Smith & Nephew, Inc.

About this trial

Last updated a year ago

Study ID

REDAPT 15-4538-02

Status

Terminated

Type

Observational

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

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.

No

Exclusion Criteria

Locations

Location

Status