RecruitingNot ApplicableNCT05357378

Safety and Effectiveness of the HIT Reverse HRS

Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study


Sponsor

Hip Innovation Technology

Enrollment

288 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and performance of the HIT Reverse Hip Replacement System — a new total hip replacement (THA) implant — in patients with non-inflammatory degenerative joint disease (such as osteoarthritis or avascular necrosis). The study tracks how well patients recover and how long the implant lasts. You may be eligible if... - You are between 50 and 75 years old - You need a primary (first-time) total hip replacement on one side - Your hip problem is due to osteoarthritis, avascular necrosis, post-traumatic arthritis, or similar non-inflammatory causes - You have been medically cleared for surgery - You are willing to attend all follow-up visits You may NOT be eligible if... - You have had a hip replacement, hemi-arthroplasty, or fusion in the other hip within the last 2 years (or more than 2 years ago but still causing pain) - You need a bilateral hip replacement or plan to have the other hip done within 2 years - You need a knee replacement within the next 2 years - You have a known allergy to titanium, XLPE, or cobalt chromium (CoCr) - You have had a joint infection in the affected hip - You have a BMI of 40 or higher - You have an active malignancy or history of cancer within the last 5 years (with exceptions) - You have rheumatoid arthritis, lupus, or another inflammatory joint disease - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHip 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.

DEVICEAlready-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

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NCT05357378


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