Safety and Effectiveness of the HIT Reverse HRS

NARecruitingINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

July 15, 2022

Primary Completion Date

July 15, 2026

Study Completion Date

July 15, 2035

Conditions
Degenerative Joint DiseaseOsteoarthritis, HipAvascular Necrosis of HipTraumatic Arthropathy-Hip
Interventions
DEVICE

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.

DEVICE

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"

Trial Locations (6)

21215

RECRUITING

LifeBridge Health Rubin Institute for Advanced Orthopedics, Baltimore

33186

SUSPENDED

Miami Institute for Joint Reconstruction, Miami

33614

RECRUITING

Advent Health Hospital, Carrollwood, Tampa

33615

NOT_YET_RECRUITING

Tampa General Health / Florida Orthopedic Institute, Tampa

43054

RECRUITING

JIS Orthopedics, New Albany

08244

RECRUITING

Division of Orthopaedic Surgery, Somers Point

Sponsors
All Listed Sponsors
lead

Hip Innovation Technology

INDUSTRY