Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03610789
Recruitment Status : Enrolling by invitation
First Posted : August 1, 2018
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hip Replacement Device: REDAPT

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Other
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

Group/Cohort Intervention/treatment
REDAPT Revision Femoral System
REDAPT Revision Femoral System Monolithic Sleeveless Stems, monolithic sleeved stems and/or Acetabular Components or modular shells and/or augments
Device: REDAPT
REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

Subjects must meet all of the inclusion criteria to enroll in the study:

  1. Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
  2. 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.
  3. Subject required surgery with REDAPT device chosen for one of the following indications:

    1. 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).
    2. Fracture-dislocation of the hip, femoral neck fracture or trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
    3. Revision THA
  4. 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.
  5. 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:

  1. Subject had an active infection - systemic or at the site of surgery.
  2. 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.
  3. Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
  4. Subject is incarcerated or is pending incarceration.
  5. Subject is enrolled in another clinical study that would affect the endpoints of the study.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
Eisenhower Medical Center-Hospital
Rancho Mirage, California, United States, 92270
Scripps Mercy
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
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Layout table for investigator information
Study Chair: Rob Bedford Smith & Nephew, Inc.
Layout table for additonal information
Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03610789    
Other Study ID Numbers: REDAPT 17-4538-02
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes