- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02344160
REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness
December 15, 2016 updated by: Smith & Nephew, Inc.
A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System
The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years.
Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.
Study Overview
Detailed Description
This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™.
The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes.
The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Irvine, California, United States, 92868
- Ran Schwarzkopf
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
340 subjects
Description
Inclusion Criteria:
- Subject requires revision hip arthroplasty
- Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant
- Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
- Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
- Endoprosthesis, femoral osteotomy, or Girdlestone resection
- Subject is at least 18 years of age
- Subject is skeletally mature in Investigators judgment
- Subject is willing to consent to participate in the study
- Subject is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
Exclusion Criteria:
- Known allergies to any components of the devices
- Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Subject is facing current or impending incarceration
- Female subject is of child-bearing age and not using an approved method of contraception
- Mental or neurological conditions which could impair the subject's ability or willingness to comply with the study
- Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.
- Skeletal immaturity
- Subject is severely overweight (BMI > 40)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stem revision
Time Frame: 5 years with additional follow up to 10 years
|
the primary outcome will be assessed by the incidence of stem revision
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5 years with additional follow up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revision for any reason
Time Frame: 5 years with additional follow-up to 10 years
|
Revision for any reason
|
5 years with additional follow-up to 10 years
|
Radiographic Measurements
Time Frame: post operatively with additional follow-up to 10 years
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radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential change over time.
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post operatively with additional follow-up to 10 years
|
Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)
Time Frame: At baseline and up to 10 year follow up
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Subject reported outcomes will be collected and scored over time to assess change over time from baseline to 10 year post REDAPT Revision surgery
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At baseline and up to 10 year follow up
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Harris Hip Score
Time Frame: at baseline and follow up visits up to 10 year follow up post surgically
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Clinical evaluations to score and assess changes over time from baseline to 10 year follow up post REDAPT Revision surgery
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at baseline and follow up visits up to 10 year follow up post surgically
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Number of participants with Adverse Events
Time Frame: Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery
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Adverse events will be collected to monitor safety
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Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery
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Metal Ion measurement in whole blood
Time Frame: baseline and at each study visit up to 10 years following REDAPT REvison surgery.
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blood will be analysed for metal ion levels at baseline and each study visit up to 10 years to assess change in serum metal ion level over time.
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baseline and at each study visit up to 10 years following REDAPT REvison surgery.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Waddell, MD, St. Michaels Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2028
Study Completion (Anticipated)
December 1, 2028
Study Registration Dates
First Submitted
January 14, 2015
First Submitted That Met QC Criteria
January 16, 2015
First Posted (Estimate)
January 22, 2015
Study Record Updates
Last Update Posted (Estimate)
December 16, 2016
Last Update Submitted That Met QC Criteria
December 15, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-4538-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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