REDAPT Retrospective-Prospective Modular Stem Study

Arthroplasties, Hip Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02661620
• Other study ID #: REDAPT 15-4538-02
• Status: Terminated
• Start date: February 2016
• Est. completion date: April 16, 2020

Study information

• Verified date: April 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasties, Hip Replacement

Intervention

Device:
• REDAPT Revision Femoral System modular stem
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Modular stem revision	Listing of stem implant status at 5 years to analyze stem survival rate	5 years post operatively
Secondary	Revision of any component for any reason	revision for any reason	5 year post operative
Secondary	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
Secondary	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
Secondary	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