Clinical trial NCT02344160: REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness
Official title: A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Total Hip Arthroplasty (THA)
Keywords: Total Hip Arthroplasty
THA
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 340 subjects

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Stem revision
timeFrame: 5 years with additional follow up to 10 years
Secondary outcomes:
measure: Revision for any reason
timeFrame: 5 years with additional follow-up to 10 years
measure: Radiographic Measurements
timeFrame: post operatively with additional follow-up to 10 years
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)
timeFrame: At baseline and up to 10 year follow up
measure: Harris Hip Score
timeFrame: at baseline and follow up visits up to 10 year follow up post surgically
measure: Number of participants with Adverse Events
timeFrame: Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery
measure: Metal Ion measurement in whole blood
timeFrame: baseline and at each study visit up to 10 years following REDAPT REvison surgery.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Ran Schwarzkopf
state: California
Study officials:
affiliation: St. Michaels Hospital
name: James Waddell, MD
role: PRINCIPAL_INVESTIGATOR
References: