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® 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
Control Arm subjects will receive one of the already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. * 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
Miami Institute for Joint Reconstruction
Miami, Florida, United States
RECRUITINGAdvent Health Hospital, Carrollwood
Tampa, Florida, United States
RECRUITINGTampa General Health / Florida Orthopedic Institute
Tampa, Florida, United States
OHS of 36 or more at the 2-year follow-up visit
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).
Time frame: 24 months
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.
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).
Time frame: 24 months
Radiologic success at the 2-year follow-up
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.
Time frame: 24 months
Absence of revision at the 2-year follow-up visit
No reoperations that led to removal or replacement of any of the acetabular or femoral components.
Time frame: 24 months
Change in OHS compared to baseline at all follow-up visits.
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).
Time frame: 24 months
Change in HHS compared to baseline at all follow-up visits.
The Harris Hip Score (HHS) is a clinician-based 10-item questionnaire used to evaluate the results of hip surgery. It is comprised of 4 sub-sections yielding a maximum possible score of 100 points collectively, including pain (44 points), function (47 points), absence of deformity (4 points), and range of motion (5 points). Measured as Cohen's effect size, the improvements of THA are in the range of 3 and higher (Singh et al., 2016). The traditional categorization of HHS is: \< 70, poor; 70-79, fair; 80-89, good; and 90-100, excellent.
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LifeBridge Health Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, United States
RECRUITINGDivision of Orthopaedic Surgery
Somers Point, New Jersey, United States
RECRUITINGJIS Orthopedics
New Albany, Ohio, United States
RECRUITINGTime frame: 24 months