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

NCT02344160 | Withdrawn

• 1 other identifier: 13-4538-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty (THA)

Keywords

Total Hip Arthroplasty; THA

Outcome Measures

Primary Outcomes (1)

• Stem revision

  the primary outcome will be assessed by the incidence of stem revision

  5 years with additional follow up to 10 years

Secondary Outcomes (6)

• Revision for any reason

  5 years with additional follow-up to 10 years

• Radiographic Measurements

  post operatively with additional follow-up to 10 years

• Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)

  At baseline and up to 10 year follow up

• Harris Hip Score

  at baseline and follow up visits up to 10 year follow up post surgically

• 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

Interventions

Phlebotomy OTHER

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

Also known as: blood draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

340 subjects

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Ran Schwarzkopf

Irvine, California, 92868, United States

Location

MeSH Terms

Interventions

Phlebotomy; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• James Waddell, MD

  St. Michaels Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 22, 2015
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

US (1)