Safety and Effectiveness of the HIT Reverse HRS

Last updated: June 27, 2025
Sponsor: Hip Innovation Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Arthritis And Arthritic Pain (Pediatric)

Osteoarthritis

Treatment

Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.

Hip Innovation Technology Reverse Hip Replacement System

Clinical Study ID

NCT05357378
HIT-002
  • Ages 50-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient requires primary THA due to NIDJD or any of its composite diagnoses such asosteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capitalepiphysis, fracture of the pelvis, and diastrophic variant requiring unilateralprimary THA.

  • Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time ofenrollment.

  • Patient has preoperative medical clearance and is free from or treated for medicalconditions that would pose excessive operative risk.

  • Patient has a signed and dated Informed Consent Form (ICF).

  • Patient is willing and able to participate in required follow-up visits at theinvestigational site and to complete study procedures and questionnaires.

Exclusion

Exclusion Criteria:

  • Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateralhip in the last 24 months.

  • Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateralhip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2on a Numeric Rating Scale 0-10.

  • Patient needs bilateral hip replacement or has a planned THA on the contralateralhip joint in the next 24 months.

  • Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.

  • Patient has a known allergy to titanium and/or XLPE.

  • Patient has known metal sensitivities to cobalt chromium (CoCr).

  • Patient has a history of septic arthritis in the index joint.

  • Patient has insufficient acetabular or femoral bone stock in which good anchorage ofthe implants is unlikely or impossible.

  • Patient has total or partial absence of the muscular or ligamentous apparatus.

  • Patient has known moderate to severe renal insufficiency.

  • Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease ineither leg (based on the Investigator's judgment).

  • Patient has a deformity of the affected limb or significant anatomic variance of theaffected hip.

  • Patient has an active malignancy or history of invasive malignancy within the last 5years, except for superficial basal cell carcinoma or squamous cell carcinoma of theskin that has been definitively treated. Patients with carcinoma in situ of theuterine cervix definitively treated more than 1 year prior to enrollment may enterthe study.

  • Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.

  • Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoidarthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenilerheumatoid arthritis, and other arthritic processes of inflammatory or autoimmuneetiology.

  • Patient has any condition that would interfere with self-assessment of pain,function, or quality of life (QoL) required for patient-reported outcomes during thestudy (based on the Investigator's judgment).

  • Patient has a Body Mass Index (BMI) of 40 or higher.

  • Patient has an active infection (e.g., hepatitis, Acquired Immune DeficiencySyndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of theintended surgery.

  • Patient is currently participating in any investigational study not related to thisstudy's preoperative or postoperative care.

  • Patient is currently pregnant or is planning to become pregnant during the study.

  • Patient is a competitive or professional athlete.

Study Design

Total Participants: 288
Treatment Group(s): 2
Primary Treatment: Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
Phase:
Study Start date:
July 15, 2022
Estimated Completion Date:
July 15, 2035

Study Description

This is a randomized, controlled, multi-center clinical trial. Subjects meeting inclusion and exclusion criteria will be recruited from patients undergoing primary THA at up to 20 investigational sites. Subjects in the Experimental Arm will receive the Investigational Device. Subjects in the Control Arm will receive one of the already-marketed semi constrained uncemented hip systems using a metal on highly cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination. The following hip systems will be eligible for subjects in the Control Arm:

  • 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.

Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms.

Connect with a study center

  • Miami Institute for Joint Reconstruction

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Advent Health Hospital, Carrollwood

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Tampa General Health / Florida Orthopedic Institute

    Tampa, Florida 33615
    United States

    Site Not Available

  • LifeBridge Health Rubin Institute for Advanced Orthopedics

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

  • Division of Orthopaedic Surgery

    Somers Point, New Jersey 08244
    United States

    Active - Recruiting

  • JIS Orthopedics

    New Albany, Ohio 43054
    United States

    Active - Recruiting

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