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RECRUITING
NCT05357378
NA

Safety and Effectiveness of the HIT Reverse HRS

Sponsor: Hip Innovation Technology

View on ClinicalTrials.gov

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

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

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