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REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness | Clinical Trials | Clareo Health

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REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness

A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System

NCT02344160•Smith & Nephew, Inc.

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

Ran Schwarzkopf

Irvine, California, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

December 16, 2016

Conditions

Total Hip Arthroplasty (THA)

Interventions

Phlebotomy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness

Inclusion Criteria

Exclusion Criteria

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