Restoration Anatomic Acetabular Shell Revision Study

Launched by STRYKER ORTHOPAEDICS · Oct 19, 2022

Keywords

ClinConnect Summary

The Restoration Anatomic Acetabular Shell Revision Study is looking into how well a specific hip implant works for patients who have had a previous hip surgery that didn't succeed. This study will follow people both from the past and going forward to see how long the new implant lasts and how well it helps with their hip problems, like arthritis. The study is currently recruiting participants of all ages and genders who meet certain criteria.

To join this study, participants need to be having a revision surgery for their failed hip implant and must be in good enough health to handle the procedure. They should be willing to attend follow-up appointments to monitor their recovery. However, people with certain health issues, such as severe obesity, active infections, or specific bone or systemic diseases, may not qualify. If eligible, participants can expect close monitoring of their recovery and the performance of the new implant.

Gender

ALL

Eligibility 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.