REDAPT Retrospective-Prospective Modular Stem Study

NCT02661620 | Terminated

• 1 other identifier: REDAPT 15-4538-02
• Study Type: observational
• Target: 140
• Locations: 3 countries
• Sites: 5

Brief 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

Keywords

REDAPT Femoral System modular stem implant; Total Hip arthroplasty revision

Outcome Measures

Primary Outcomes (1)

• Modular stem revision

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

  5 years post operatively

Secondary Outcomes (4)

• Revision of any component for any reason

  5 year post operative

• Radiographic assessments

  follow-up to 10 years as per standard of care

• Harris Hip Score

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

• Adverse Events

  through study completion, an average of 10 years

Other Outcomes (2)

• Whole blood metal ion level assessment for cobalt and chromium

  through study completion, an average of 10 years

• MARS MRI or CT images acquired pending outcome of whole blood metal ion level assessment

  based on results of outcome 6, through study completion, an average of 10 years

Interventions

REDAPT Revision Femoral System modular stem DEVICE

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 of this protocol at the study site.

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

Baptist Health Louisville Orthopedic

Louisville, Kentucky, 40207, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

The Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

ZNA Campus Middelheim, Antwerpe

Antwerp, Belgium

Location

CHU De Quebec- Hôpital Saint-François d'Assise

Québec, Quebec, G1L 3L5, Canada

Location

Study Officials

• Rachel Jahnke

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 22, 2016
• Study Start: February 1, 2016
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); BE (1); CA (1)