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

Smith & Nephew

Status: Withdrawn

Conditions: Total Hip Arthroplasty (THA)

Treatments: Other: Phlebotomy

Study type: Observational

Funder types: Industry

Identifiers

NCT02344160

13-4538-02

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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)