REDAPT Retrospective-Prospective Modular Stem Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- Modular stem revision [5 years post operatively]
Listing of stem implant status at 5 years to analyze stem survival rate
Secondary Outcome Measures
- Revision of any component for any reason [5 year post operative]
revision for any reason
- Radiographic assessments [follow-up to 10 years as per standard of care]
radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential changeover time
- Harris Hip Score [collect retrospectively from medical record preoperative and if done preoperatively at 1 year, 5 year and 10 year follow up visits]
Clinical evaluation to score and assess changes over time from baseline through 10 year post.
- Adverse Events [through study completion, an average of 10 years]
Adverse events will be collected to monitor the safety, retrospectively from medical record review starting with operative date through end of study
Other Outcome Measures
- Whole blood metal ion level assessment for cobalt and chromium [through study completion, an average of 10 years]
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)
- 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]
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)
Eligibility Criteria
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:
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Subject completed limited retrospective data collection phase and willing to consent to expanded retrospective data collection and the prospective phase of the study;
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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:
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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
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Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baptist Health Louisville Orthopedic | Louisville | Kentucky | United States | 40207 |
| 2 | Detroit Receiving Hospital | Detroit | Michigan | United States | 48201 |
| 3 | The Oregon Health & Science University | Portland | Oregon | United States | 97239-3098 |
| 4 | ZNA Campus Middelheim, Antwerpe | Antwerp | Belgium | ||
| 5 | CHU De Quebec- Hôpital Saint-François d'Assise | Quebec City | Quebec | Canada | G1L 3L5 |
Sponsors and Collaborators
- Smith & Nephew, Inc.
Investigators
- Study Chair: Rachael Winter, Smith & Nephew, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REDAPT 15-4538-02