REDAPT Retrospective-Prospective Modular Stem Study

A Retrospective-Prospective Study of REDAPT™ Revision Femoral System Modular Stem

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.

Study Overview

• Status: Terminated
• Conditions: Arthroplasties, Hip Replacement
• Intervention / Treatment: Device: REDAPT Revision Femoral System modular stem

Detailed Description

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 (Actual): 140

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • ZNA Campus Middelheim, Antwerpe
• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1L 3L5
      • CHU De Quebec- Hôpital Saint-François d'Assise
• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Baptist Health Louisville Orthopedic
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Receiving Hospital
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • The Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modular stem revision	Listing of stem implant status at 5 years to analyze stem survival rate	5 years post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision of any component for any reason	revision for any reason	5 year post operative
Radiographic assessments	radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential changeover time	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.	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	through study completion, an average of 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole blood metal ion level assessment for cobalt and chromium	performed for subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI)	through study completion, an average of 10 years
MARS MRI or CT images acquired pending outcome of whole blood metal ion level assessment	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)	based on results of outcome 6, through study completion, an average of 10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Rachel Jahnke, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): April 16, 2020
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimated): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: REDAPT Femoral System modular stem implant; Total Hip arthroplasty revision
• Other Study ID Numbers: REDAPT 15-4538-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO