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Safety and Effectiveness of the HIT Reverse HRS

NCT05357378 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Degenerative Joint Disease
  • Osteoarthritis, Hip
  • Avascular Necrosis of Hip
  • Traumatic 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

Sponsors & Collaborators

  • Hip Innovation Technology

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2026-07-15
Completion
2035-07-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357378 on ClinicalTrials.gov