Restoration Anatomic Acetabular Shell Revision Study
Stopped: Due to due to inability to recruit sufficient eligible participants.
United States0Started 2024-03-02
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has a status of 'withdrawn,' meaning it never enrolled any patients — so is there a similar active study looking at the Restoration Anatomic Acetabular Shell for revision hip surgery that I could potentially be considered for?
2Since this was a revision hip surgery study, does my situation actually involve a failed or failing previous hip replacement, and would revision surgery even be the right path for me compared to other options?
3Because the trial was withdrawn before collecting any data, what does my care team currently know about the success rates and safety of the Restoration Anatomic Acetabular Shell specifically for revision procedures?
4Given that this trial never got off the ground, are there other approved or investigational approaches to acetabular revision that have more supporting evidence I should be aware of?
5Would it make sense for me to seek a second opinion at a major orthopedic center that may be running active revision hip surgery research, so I can understand all my options before making a decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.