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Safety and Effectiveness of the HIT Reverse HRS
Sponsor: 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.
Official title: Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
Key Details
Gender
All
Age Range
50 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2022-07-15
Completion Date
2035-07-15
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
Hip Innovation Technology Reverse Hip Replacement System
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.
Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
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
Locations (6)
Miami Institute for Joint Reconstruction
Miami, Florida, United States
Advent Health Hospital, Carrollwood
Tampa, Florida, United States
Tampa General Health / Florida Orthopedic Institute
Tampa, Florida, United States
LifeBridge Health Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, United States
Division of Orthopaedic Surgery
Somers Point, New Jersey, United States
JIS Orthopedics
New Albany, Ohio, United States