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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Total Hip Arthroplasty (THA)

Keywords

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Total Hip Arthroplasty THA

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Phlebotomy

Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures

Intervention Type OTHER

Other Intervention Names

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blood draw

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Waddell, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michaels Hospital

Locations

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Ran Schwarzkopf

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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13-4538-02

Identifier Type: -

Identifier Source: org_study_id