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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REDAPT Revision Femoral System | REDAPT Revision Femoral System Monolithic Sleeveless Stems, monolithic sleeved stems and/or Acetabular Components or modular shells and/or augments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REDAPT | Device | REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision rate | 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. | 10 years post-op |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQul Five Dimensions Questionnaire EQ-5D-5L | 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. |
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Inclusion Criteria:
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:
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.
Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria will be excluded from study participation:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nahomie Prophete | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisenhower Medical Center-Hospital | Rancho Mirage | California | 92270 | United States | ||
| Scripps Mercy |
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| Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively |
| Functional outcomes as determined by the Hip Disability Osteoarthritis Outcome (HOOS) score | 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. | Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively |
| Radiographic assessments | 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. | Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively |
| San Diego |
| California |
| 92103 |
| United States |
| NYU Langone Health Orthopedic Hospital | New York | New York | 10003 | United States |
| Hospital for Surgery- New York | New York | New York | 10021 | United States |