Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Joint Disease
- Sponsor
- Hip Innovation Technology
- Enrollment
- 288
- Locations
- 6
- Primary Endpoint
- OHS of 36 or more at the 2-year follow-up visit
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Detailed 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 ACTIS™ Total Hip System in combination with DePuy Synthes PINNACLE™ Complete Acetabular Hip System; * Zimmer Biomet Taperloc®, Zimmer Z1™ Cementless Femoral Hip Stem System or Zimmer Biomet AVENIR® Complete Hip System in combination with Zimmer Biomet 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 Smith \& Nephew R3® Acetabular System. Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms.
Investigators
Eligibility Criteria
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 able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
Exclusion Criteria
- •Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
- •Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-
- •Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
- •Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
- •Patient has a known allergy to titanium and/or XLPE.
- •Patient has known metal sensitivities to cobalt chromium (CoCr).
- •Patient has a history of septic arthritis in the index joint.
- •Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is unlikely or impossible.
- •Patient has total or partial absence of the muscular or ligamentous apparatus.
- •Patient has known moderate to severe renal insufficiency.
Outcomes
Primary Outcomes
OHS of 36 or more at the 2-year follow-up visit
Time Frame: 24 months
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.
Time Frame: 24 months
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Radiologic success at the 2-year follow-up
Time Frame: 24 months
Defined as * No radiolucencies greater than 2 mm in 50% or more of the cup or stem zones; * No femoral or acetabular subsidence greater than or equal to 5 mm from baseline; * No acetabular cup inclination change greater than 4 degrees from baseline.
Absence of revision at the 2-year follow-up visit
Time Frame: 24 months
No reoperations that led to removal or replacement of any of the acetabular or femoral components.
Secondary Outcomes
- Change in HHS compared to baseline at all follow-up visits.(24 months)
- Change in OHS compared to baseline at all follow-up visits.(24 months)