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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
Regents of the University of Colorado
RECRUITING
Denver
Contact Information
Primary
Sabrina Cristofaro
sabrina.cristofaro@stryker.com
5513298665
Backup
Marissa Puccio
marissa.puccio@stryker.com
2016751416
Time Frame
Start Date: 2024-03-02
Estimated Completion Date: 2036-03-01
Participants
Target number of participants: 56
Treatments
Other: Restoration Anatomic Acetabular Shell
Related Therapeutic Areas
Sponsors
Leads: Stryker Orthopaedics