Evaluating the HIT Reverse Hip Replacement System for total hip replacement

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

This study is testing a new hip replacement system to see if it works better and is safer than the standard hip replacement for people needing surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Hip Innovation Technology (industry)
• Locations: 6 sites (Miami, Florida and 5 other locations)
• Trial ID: NCT05357378 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the HIT Reverse Hip Replacement System in patients undergoing total hip arthroplasty (THA). It is a randomized, controlled, multi-center trial involving up to 20 investigational sites. Participants will be divided into two groups: one receiving the investigational device and the other receiving a standard marketed hip replacement system. The study will monitor outcomes related to surgery, post-surgical care, and rehabilitation according to standard practices.

Who should consider this trial

Good fit: Ideal candidates are patients aged 50 to 75 who require primary total hip arthroplasty due to degenerative joint disease or related conditions.

Not a fit: Patients who have had previous hip surgeries or those with certain medical conditions that pose excessive operative risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective option for patients requiring hip replacement surgery.

How similar studies have performed: Other studies have shown success with similar hip replacement approaches, indicating potential for positive outcomes.

Eligibility criteria

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.

Where this trial is running

Miami, Florida and 5 other locations

• Miami Institute for Joint Reconstruction — Miami, Florida, United States (RECRUITING)
• Advent Health Hospital, Carrollwood — Tampa, Florida, United States (RECRUITING)
• Tampa General Health / Florida Orthopedic Institute — Tampa, Florida, United States (RECRUITING)
• LifeBridge Health Rubin Institute for Advanced Orthopedics — Baltimore, Maryland, United States (TERMINATED)
• Division of Orthopaedic Surgery — Somers Point, New Jersey, United States (RECRUITING)
• JIS Orthopedics — New Albany, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: George Diamantoni

Conditions: Degenerative Joint Disease, Osteoarthritis, Hip, Avascular Necrosis of Hip, Traumatic Arthropathy-Hip, total hip arthroplasty