What is the HIT Reverse Hip Replacement System studying for hip conditions?

The HIT Reverse Hip Replacement System is being studied to see if it is safe and effective for patients needing total hip replacement surgery. Researchers compare it to other commonly used hip replacement devices to understand its performance. This research is led by Hip Innovation Technology to improve treatment options for hip joint diseases.

Who may be eligible for this hip replacement clinical trial?

Adults aged 50 to 75 years who need a primary total hip replacement due to conditions like osteoarthritis or avascular necrosis may be eligible. Both men and women can participate. Important factors include being medically cleared for surgery and able to attend follow-up visits. Please review eligibility criteria for more details.

Is there any cost to participate in this hip replacement clinical trial?

Study-related care, including the study device, surgery, and all trial visits, is provided at no cost. However, personal expenses such as travel or lodging may not be covered and can vary. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 50Years - 75Years

All Genders

ID05357378

Study of the Hip Innovation Technology Reverse Hip Replacement System Compared to Other Hip Systems in Adults Undergoing Primary Total Hip Replacement Surgery

Led by Hip Innovation Technology · Updated on 2026-05-11

288

Participants Needed

Research Sites

469 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the HIT Reverse Hip Replacement System in patients undergoing primary total hip arthroplasty THA. This randomized, controlled, multi-center clinical trial compares the investigational device to established semi-constrained uncemented hip systems that use metal-on-highly cross-linked polyethylene XLPE or ceramic-on-XLPE bearing combinations. The study aims to determine whether the new system meets specific safety and performance standards compared to the control devices. Participants will be randomly assigned to receive either the HIT Reverse HRS investigational device or one of several marketed hip replacement systems, including options from DePuy Synthes, Zimmer Biomet, Stryker, and Smith & Nephew. The surgeries and post-surgical care follow standard procedures for total hip replacement, with implantation performed according to the instructions for use IFU of the assigned device. Both groups will undergo usual rehabilitation and follow-up care. During the study, participants will attend follow-up visits up to two years after surgery to assess outcomes such as the Oxford Hip Score OHS, Harris Hip Score HHS, radiologic success, and any need for revision surgery. Researchers will monitor these measures to evaluate hip function and device performance. Participants will complete questionnaires and clinical assessments at regular intervals. The total participation duration includes surgery and a two-year follow-up period for safety and effectiveness evaluation.

CONDITIONS

Brief Title

Safety and Effectiveness of the HIT Reverse HRS

Who Can Participate

Age: 50Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Patient requires primary total hip arthroplasty due to degenerative joint disease or related conditions such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, pelvis fracture, or diastrophic variant.
Patient is between 50 and 75 years old at enrollment.
Patient has medical clearance and is free from or treated for conditions posing excessive surgical risk.
Patient has signed the informed consent form.
Patient is willing and able to attend required follow-up visits and complete study procedures and questionnaires.

You will not qualify if you...

Patient had earlier total hip arthroplasty, hemi-arthroplasty, or fusion in the opposite hip within the last 24 months.
Patient had earlier hip surgery in the contralateral hip more than 24 months ago with a pain rating of 2 or higher on a 0-10 scale.
Patient needs or plans bilateral hip replacement or contralateral hip surgery in the next 24 months.
Patient needs or plans knee replacement surgery in the next 24 months.
Patient has allergies to titanium or highly cross-linked polyethylene (XLPE).
Patient has metal sensitivity to cobalt chromium.
Patient has a history of septic arthritis in the affected joint.
Patient has insufficient bone stock for implant anchorage.
Patient has partial or total absence of muscular or ligamentous structures.
Patient has moderate to severe kidney problems.
Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg.
Patient has deformity or significant anatomic variance of the affected hip.
Patient has active or recent invasive cancer (except certain treated skin cancers).
Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
Patient has inflammatory joint disease or autoimmune arthritis.
Patient has conditions interfering with self-assessment of pain, function, or quality of life.
Patient has a body mass index of 40 or higher.
Patient has an active infection such as hepatitis or AIDS.
Patient is currently in another investigational study unrelated to this surgery.
Patient is pregnant or plans pregnancy during the study.
Patient is a competitive or professional athlete.

Research Team

George Diamantoni

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Study of the Hip Innovation Technology Reverse Hip Replacement System Compared to Other Hip Systems in Adults Undergoing Primary Total Hip Replacement Surgery

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria