Hip Osteoarthritis Clinical Trial
— RASOfficial title:
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
NCT number | NCT05591859 |
Other study ID # | 105 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2024 |
Est. completion date | March 1, 2036 |
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.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | March 1, 2036 |
Est. primary completion date | March 1, 2036 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 or about the affected hip joint at time of study device implantation. - Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. - Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis. - Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. - Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. > 30 days). - Subject has a known sensitivity to device materials. - Subject is a prisoner. |
Country | Name | City | State |
---|---|---|---|
United States | Regents of the University of Colorado | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Stryker Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate | Success rate is defined as no incidence of revision for aseptic loosening | 10 years | |
Secondary | Adverse Events | All protocol defined adverse events as well as all-cause revision and/or removal of RAS | 10 years |
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