Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
Hip Innovation Technology
Summary
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.
Description
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® or DePuy Synthes…
Eligibility
- Age range
- 50–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA. * Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment. * Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk. * Patient has a signed and dated Informed Consent Form (ICF). * Patient is willing and abl…