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
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|ClinicalTrials.gov Identifier: NCT03610789|
Recruitment Status : Enrolling by invitation
First Posted : August 1, 2018
Last Update Posted : March 1, 2021
|Condition or disease||Intervention/treatment|
|Hip Replacement||Device: REDAPT|
|Study Type :||Observational|
|Estimated Enrollment :||220 participants|
|Official Title:||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|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||December 1, 2030|
|Estimated Study Completion Date :||December 1, 2030|
REDAPT Revision Femoral System
REDAPT Revision Femoral System Monolithic Sleeveless Stems, monolithic sleeved stems and/or Acetabular Components or modular shells and/or augments
REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components
- Revision rate [ Time Frame: 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.
- EuroQul Five Dimensions Questionnaire EQ-5D-5L [ Time Frame: 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 [ Time Frame: 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.
- Radiographic assessments [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610789
|United States, California|
|Eisenhower Medical Center-Hospital|
|Rancho Mirage, California, United States, 92270|
|San Diego, California, United States, 92103|
|United States, New York|
|NYU Langone Health Orthopedic Hospital|
|New York, New York, United States, 10003|
|Hospital for Surgery- New York|
|New York, New York, United States, 10021|
|Study Chair:||Rob Bedford||Smith & Nephew, Inc.|