Osteoarthritis, Hip Clinical Trial
Official title:
Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
This is a randomized, controlled, multi-center clinical trial. Subjects meeting inclusion and exclusion criteria will be recruited from patients undergoing primary THA at up to 20 investigational sites. Subjects in the Experimental Arm will receive the Investigational Device. Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination. The following hip systems will be eligible for subjects in the Control Arm: - DePuy Synthes Corail® Total Hip System in combination with Pinnacle® Complete Acetabular Hip System; - Zimmer Biomet Taperloc® Complete Hip System in combination with G7® Acetabular System; - Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup; - Smith & Nephew Anthology® Total Hip System in combination with R3® Acetabular System. Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms. ;
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