Clinical trial NCT02661620: REDAPT Retrospective-Prospective Modular Stem Study
Official title: A Retrospective-Prospective Study of REDAPT™ Revision Femoral System Modular Stem
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthroplasties, Hip Replacement
Keywords: REDAPT Femoral System modular stem implant
Total Hip arthroplasty revision
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-22
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modular stem revision
timeFrame: 5 years post operatively
Secondary outcomes:
measure: Revision of any component for any reason
timeFrame: 5 year post operative
measure: Radiographic assessments
timeFrame: follow-up to 10 years as per standard of care
measure: Harris Hip Score
timeFrame: collect retrospectively from medical record preoperative and if done preoperatively at 1 year, 5 year and 10 year follow up visits
measure: Adverse Events
timeFrame: through study completion, an average of 10 years
Other outcomes:
measure: Whole blood metal ion level assessment for cobalt and chromium
timeFrame: through study completion, an average of 10 years
measure: MARS MRI or CT images acquired pending outcome of whole blood metal ion level assessment
timeFrame: based on results of outcome 6, through study completion, an average of 10 years
Locations:
city: Louisville
country: United States
facility: Baptist Health Louisville Orthopedic
state: Kentucky
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Portland
country: United States
facility: The Oregon Health & Science University
state: Oregon
city: Antwerp
country: Belgium
facility: ZNA Campus Middelheim, Antwerpe
city: Quebec City
country: Canada
facility: CHU De Quebec- Hôpital Saint-François d'Assise
state: Quebec
Study officials:
affiliation: Smith & Nephew, Inc.
name: Rachel Jahnke
role: STUDY_CHAIR
References: