REDAPT Retrospective-Prospective Modular Stem Study

Smith & Nephew, Inc.140 enrolled

Overview

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.

The primary purpose of this study is to demonstrate the REDAPT™ Revision Femoral System modular stem cumulative revision rate at 5 years. The secondary purpose of this study is to provide 10 years of safety and performance data on the REDAPT™ Revision Femoral System modular stem in terms of Standard of Care Radiographic Assessment, Harris Hip Sore (if obtained prior to implant), adverse event assessment, whole blood metal ion level assessment for Cobalt and Chromium (only performed if subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI), and Metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) or Computed Tomography (CT) will be obtained if metal ion levels of Cobalt and/or Chromium \> 7parts per billion (ppb) 140 subjects have been enrolled in the study at 5 clinical study sites around the world. A Clinical Study Report (CSR) will be completed at years 5 and 10.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Arthroplasties, Hip Replacement

Interventions

REDAPT Revision Femoral System modular stemDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (5)

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

Outcomes

Primary Outcomes

Modular stem revision

Listing of stem implant status at 5 years to analyze stem survival rate

Time frame: 5 years post operatively

Secondary Outcomes

Revision of any component for any reason

revision for any reason

Time frame: 5 year post operative

Radiographic assessments

radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential changeover time

Time frame: follow-up to 10 years as per standard of care

Harris Hip Score

Clinical evaluation to score and assess changes over time from baseline through 10 year post.

Time frame: collect retrospectively from medical record preoperative and if done preoperatively at 1 year, 5 year and 10 year follow up visits

Adverse Events

Adverse events will be collected to monitor the safety, retrospectively from medical record review starting with operative date through end of study

Time frame: through study completion, an average of 10 years

Data from ClinicalTrials.gov

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