A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted
- Conditions
- Hip Replacement
- Interventions
- Device: REDAPT
- Registration Number
- NCT03610789
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
The primary purpose of this study is to demonstrate cumulative revision rate of the REDAPT System Monolithic Sleeveless/Sleeved Stem, Fully Porous Acetabular Shell with XLPE liner, and Modular Shell Components (with or without Staple, Slice and Blade Augments) at 10 years.
- Detailed Description
Retrospective-prospective, single arm, multicenter study of subjects previously implanted with the REDAPT System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell with XLPE liner and/or Modular Shell Components (with or without Staple, Slice and Blade Augments).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 220
Subjects must meet all of the inclusion criteria to enroll in the study:
-
Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
-
Subject has undergone hip arthroplasty with the REDAPT Fully Porous Acetabular Shell with XLPE liner or REDAPT Modular Cup Components (with or without Staple, Slice and Blade Augments), and/or Monolithic Sleeveless Stem, and/or Monolithic Sleeved Stem and are at least 3 months post-implantation at this site.
-
Subject required surgery with REDAPT device chosen for one of the following indications:
- Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, rheumatoid arthritis, or dysplasia (or any of the composites of these conditions).
- Fracture-dislocation of the hip, femoral neck fracture or trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Revision THA
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Subject is willing to consent to and to follow the study visit schedule (as defined in the study protocol and ICF), by signing the IRB/IEC approved ICF.
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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.
Subjects meeting any of the following exclusion criteria will be excluded from study participation:
- Subject had an active infection - systemic or at the site of surgery.
- 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.
- Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
- Subject is incarcerated or is pending incarceration.
- Subject is enrolled in another clinical study that would affect the endpoints of the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description REDAPT Revision Femoral System REDAPT REDAPT Revision Femoral System Monolithic Sleeveless Stems, monolithic sleeved stems and/or Acetabular Components or modular shells and/or augments
- Primary Outcome Measures
Name Time Method Revision rate 10 years post-op REDAPT System Monolithic Sleeveless/Sleeved Stem, Fully Porous Acetabular Shell with XLPE liner and Modular Shell Components (with or without Staple, Slice and Blade Augments) cumulative revision rate for any reason 10 years postoperatively.
- Secondary Outcome Measures
Name Time Method Radiographic assessments Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively Loosening as indicated by radiolucencies (RLL) \> 2mm; Lack of evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities.
EuroQul Five Dimensions Questionnaire EQ-5D-5L Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively Clinical evaluation to assess changes over time from pre-op through 10 years post-op. The EuroQol Five Dimensions (EQ-5D) Questionnaire is an instrument that derives a single index for Quality of Life (QoL) and has two sections. The first section consists of five questions covering the dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part consists of a 20-centimeter vertical VAS ranging from 0 to 100. It records the respondent's self-rated health where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. EQ-5D-5L is completed by the subject.
Functional outcomes as determined by the Hip Disability Osteoarthritis Outcome (HOOS) score Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Trial Locations
- Locations (4)
Hospital for Surgery- New York
🇺🇸New York, New York, United States
NYU Langone Health Orthopedic Hospital
🇺🇸New York, New York, United States
Eisenhower Medical Center-Hospital
🇺🇸Rancho Mirage, California, United States
Scripps Mercy
🇺🇸San Diego, California, United States