Recruiting

HIT Reverse HRS

Sponsor:

Hip Innovation Technology

Code:

NCT05357378

Conditions

Degenerative Joint Disease

Osteoarthritis, Hip

Avascular Necrosis of Hip

Traumatic Arthropathy-Hip

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Hip Innovation Technology Reverse Hip Replacement System

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

Study Details

Brief 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

Study ID

NCT05357378

Start date

Jul 15, 2022

Status verified date

May, 2026

Completion date

Jul 15, 2035

Anticipated

Primary completion date

Jul 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA.
  • Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
  • Patient has preoperative medical clearance and is free from or treated for medical conditions 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 the investigational site and to complete study procedures and questionnaires.

Exclusion Criteria:

  • Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
  • Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.
  • Patient needs bilateral hip replacement or has a planned THA on the contralateral hip 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 of the 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 in either leg (based on the Investigator's judgment).
  • Patient has a deformity of the affected limb or significant anatomic variance of the affected hip.
  • Patient has an active malignancy or history of invasive malignancy within the last 5 years, except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study.
  • Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
  • Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology.
  • Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (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 Deficiency Syndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of the intended surgery.
  • Patient is currently participating in any investigational study not related to this study'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

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm - HIT Reverse HRS

Subjects in the Experimental Arm will receive the HIT Reverse HRS Investigational Device. 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.

active comparator: Control Arm

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.

Interventions

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.

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

Primary outcome measure

  • OHS of 36 or more at the 2-year follow-up visit [ Time Frame: 24 months ]
  • Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline. [ Time Frame: 24 months ]
  • Radiologic success at the 2-year follow-up [ Time Frame: 24 months ]
  • Absence of revision at the 2-year follow-up visit [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

George Diamantoni

1-866-832-4471g.diamantoni@hit-irh.com

Locations

Miami Institute for Joint Reconstruction

Recruiting

Miami, Florida, United States, 33186

Contacts

Lauren Homolka

239-223-2573laurenhom11@gmail.com

Principal Investigator:

Arturo Corces

Advent Health Hospital, Carrollwood

Recruiting

Tampa, Florida, United States, 33614

Contacts

Anne Meredith Baldy

813-910-3693ambaldy@foreonline.org

Principal Investigator:

Steven Lyons

Tampa General Health / Florida Orthopedic Institute

Recruiting

Tampa, Florida, United States, 33615

Contacts

Anne Meredith Baldy

813-910-3693ambaldy@foreonline.org

Principal Investigator:

Michael Miranda, DO

Division of Orthopaedic Surgery

Recruiting

Somers Point, New Jersey, United States, 08244

Contacts

Stephen Zabinski

609-226-9560sjzabinski@comcast.net

Valerie Paul

609-927-1999vpaul@shoreorthodocs.com

JIS Orthopedics

Recruiting

New Albany, Ohio, United States, 43054

Contacts

David A Crawford, MD

614-221-6331CrawfordDA@jisortho.com

Michael Sneller

614-964-0348snellerma@jisortho.com

More Information

Sponsor

Hip Innovation Technology

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • total hip arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hip Innovation Technology on 2026-05-11.