Total Hip Arthroplasty (THA)
Conditions
Keywords
Total Hip Arthroplasty, THA
Brief 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.
Interventions
OTHERPhlebotomy
Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures
Sponsors
Smith & Nephew, Inc.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stem revision | 5 years with additional follow up to 10 years | the primary outcome will be assessed by the incidence of stem revision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Measurements | post operatively with additional follow-up to 10 years | radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential change over time. |
| Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D) | At baseline and up to 10 year follow up | Subject reported outcomes will be collected and scored over time to assess change over time from baseline to 10 year post REDAPT Revision surgery |
| Revision for any reason | 5 years with additional follow-up to 10 years | Revision for any reason |
| Number of participants with Adverse Events | Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery | Adverse events will be collected to monitor safety |
| Metal Ion measurement in whole blood | baseline and at each study visit up to 10 years following REDAPT REvison surgery. | 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. |
| Harris Hip Score | at baseline and follow up visits up to 10 year follow up post surgically | Clinical evaluations to score and assess changes over time from baseline to 10 year follow up post REDAPT Revision surgery |
Countries
United States
Outcome results
None listed