A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted

Launched by SMITH & NEPHEW, INC. · Jul 26, 2018

Keywords

ClinConnect Summary

Retrospective-prospective, single arm, multicenter study of subjects previously implanted with the REDAPT System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell with XLPE liner and/or Modular Shell Components (with or without Staple, Slice and Blade Augments).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all of the inclusion criteria to enroll in the study:
• • 1. Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
• • 2. Subject has undergone hip arthroplasty with the REDAPT Fully Porous Acetabular Shell with XLPE liner or REDAPT Modular Cup Components (with or without Staple, Slice and Blade Augments), and/or Monolithic Sleeveless Stem, and/or Monolithic Sleeved Stem and are at least 3 months post-implantation at this site.
• 3. Subject required surgery with REDAPT device chosen for one of the following indications:
• • 1. Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, rheumatoid arthritis, or dysplasia (or any of the composites of these conditions).
• • 2. Fracture-dislocation of the hip, femoral neck fracture or trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• • 3. Revision THA
• • 4. Subject is willing to consent to and to follow the study visit schedule (as defined in the study protocol and ICF), by signing the IRB/IEC approved ICF.
• • 5. Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
• Exclusion Criteria:
• Subjects meeting any of the following exclusion criteria will be excluded from study participation:
• • 1. Subject had an active infection - systemic or at the site of surgery.
• • 2. Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
• • 3. Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
• • 4. Subject is incarcerated or is pending incarceration.
• • 5. Subject is enrolled in another clinical study that would affect the endpoints of the study.