288
Participants
Start Date
July 15, 2022
Primary Completion Date
July 15, 2026
Study Completion Date
July 15, 2035
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"
RECRUITING
LifeBridge Health Rubin Institute for Advanced Orthopedics, Baltimore
SUSPENDED
Miami Institute for Joint Reconstruction, Miami
RECRUITING
Advent Health Hospital, Carrollwood, Tampa
NOT_YET_RECRUITING
Tampa General Health / Florida Orthopedic Institute, Tampa
RECRUITING
JIS Orthopedics, New Albany
RECRUITING
Division of Orthopaedic Surgery, Somers Point
Lead Sponsor
Hip Innovation Technology
INDUSTRY