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Post-Market Clinical Follow-up Study of the REDAPT Monolithic Sleeveless Stem and Acetabular Components Devices Used for Hip Replacement Surgery.

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 : November 26, 2019
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 Revision Femoral System Monolithic Sleeveless Stem and Acetabular Components at 10 years

Condition or disease Intervention/treatment
Hip Replacement Device: REDAPT

Detailed Description:
Retrospective-prospective, single arm, multi-center study of subjects previously implanted with the REDAPT Revision Femoral System Monolithic Sleeveless Stems and/or Acetabular Components

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Multicenter, Post-Market Clinical Follow-up Study of Subjects With REDAPT Revision Monolithic Sleeveless Stem and/or Acetabular Components Previously Implanted
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : August 1, 2028
Estimated Study Completion Date : December 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Group/Cohort Intervention/treatment
REDAPT Revision Femoral System
REDAPT Revision Femoral System Monolithic Sleeveless Stems and/or Acetabular Components
Device: REDAPT
REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components




Primary Outcome Measures :
  1. Revision rate [ Time Frame: 10 years post-op ]
    Monolithic sleeveless stem and acetabular components cumulative revision rate


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

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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™ Monolithic Sleeveless Stem and/or Acetabular Cup previously implanted prior to the date of the SIV at the study site.
Criteria

Inclusion Criteria:

  • Subject has undergone hip arthroplasty with the REDAPT Revision Femoral System Monolithic stem and/or cup Acetabular Components with implantation prior to date of Site Initiation Visit to active study.
  • Subject required surgery with REDAPT device chosen for the following indications:

    i. Complex Primary THA ii. Conversion THA iii. Periprosthetic fracture iv. Revision THA

  • Subject is willing to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the IRB/EC approved informed consent form.
  • Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion Criteria:

  • Subject surgery with REDAPT device chosen due to S/P spacer placement infection.
  • Subject, in the opinion of the principal investigator (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 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
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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
New York University Hospital for Joint Disease
New York, New York, United States, 10003
Hospital for Surgery- New York
New York, New York, United States, 10021
United States, Texas
Houston Methodist Hospital Department of Orthopedic Surgery
Houston, Texas, United States, 77030
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Tracey Brengola Smith & Nephew, Inc.

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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: November 26, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes