Evaluating a new acetabular component for hip revision surgery
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
This study is testing a new hip implant to see if it helps people who need surgery after their first hip replacement didn't work out.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Sex | All |
| Sponsor | Stryker Orthopaedics Industry-sponsored |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT05591859 on ClinicalTrials.gov |
What this trial studies
This study is a non-randomized, ambidirectional evaluation of the survivorship of the Restoration Anatomic Acetabular Shell in patients who have previously undergone total hip arthroplasty (THA) that has failed. Participants will be followed prospectively to assess the effectiveness of this new acetabular component in improving outcomes for those requiring revision surgery. The study aims to gather data from a consecutive series of eligible subjects to determine the long-term success of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals with a failed acetabular component who are suitable for revision surgery using the Restoration Anatomic Acetabular Shell.
Not a fit: Patients with a non-Stryker retained stem, high BMI, active infections, or compromised bone stock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective solution for patients undergoing revision hip surgery, potentially improving their quality of life.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in improving outcomes for revision hip surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Denver, Colorado
- Regents of the University of Colorado — Denver, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Sabrina Cristofaro
- Email: sabrina.cristofaro@stryker.com
- Phone: 5513298665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.