Arthroplasties, Hip Replacement
Conditions
Keywords
REDAPT Femoral System modular stem implant, Total Hip arthroplasty revision
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.
Interventions
DEVICEREDAPT 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.
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modular stem revision | 5 years post operatively | Listing of stem implant status at 5 years to analyze stem survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Belgium, Canada, United States
Outcome results
None listed