Restoration Anatomic Acetabular Shell Revision Study - A Post-market, Multi-center Evaluation of the Clinical Outcomes of the Restoration Anatomic Acetabular Shell in a Revision Indication
Stryker Orthopaedics
Summary
This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell. * Subject has signed an IRB-approved, study specific Informed Consent Form (ICF). * Subject is skeletally mature. * Subject is a male or non-pregnant female. * Subject is willing and able to comply with postoperative scheduled clinical evaluations. Exclusion Criteria: * Subject has a non-Stryker retained stem at the time of study device implantation. * Subject has a Body Mass Index (BMI) \> 45. * Subject has an active or suspected latent infection in o…
Interventions
- DeviceRestoration Anatomic Acetabular Shell
Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.
Location
- Regents of the University of ColoradoDenver, Colorado