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HIT Reverse Hip Replacement System for Degenerative Joint Disease

This study is testing the safety and effectiveness of a new hip replacement system called the HIT Reverse Hip Replacement System. It's for people aged 50 to 75 who need a total hip replacement due to conditions like osteoarthritis or avascular necrosis (bone tissue death due to lack of blood supply) in the hip. Researchers will compare the HIT Reverse Hip Replacement System to other hip systems that are already on the market. Success in this study means participants have good hip function (measured by the Oxford Hip Score, OHS) and good X-ray results two years after surgery. The study aims to enroll 288 participants, but its current status is unclear.

Study design
This is a randomized, controlled study, meaning participants are assigned by chance to receive either the new HIT Reverse Hip Replacement System or an already-marketed hip system. Up to 288 participants will be enrolled across multiple medical centers.
What's involved
Participants will undergo standard total hip replacement surgery. Post-surgical care and rehabilitation will follow typical procedures. Follow-up visits will occur for at least two years after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least two years after their hip replacement surgery, with assessments at the 24-month mark.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05357378

Safety and Effectiveness of the HIT Reverse HRS

Recruiting
NAAges 50–75InterventionalTreatment
Hip Innovation Technology
~288 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Hip Innovation Technology Reverse Hip Replacement SystemAlready-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
OHS of 36 or more at the 2-year follow-up visit
Measured over 24 months
+3 more outcomes measured

Conditions

Degenerative Joint Disease
Osteoarthritis, Hip
Avascular Necrosis of Hip
Traumatic Arthropathy-Hip

Explore related trials

OsteoarthritisOsteonecrosis of hipTraumatic arthropathy-hip

Where it's being run

6 sites across 4 states
Florida3
Maryland1
New Jersey1
Ohio1

Who to contact

George Diamantoni
[email protected]
1-866-832-4471
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • OHS of 36 or more at the 2-year follow-up visit24 months

    The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).

  • Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.24 months

    The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).

  • Radiologic success at the 2-year follow-up24 months

    Defined as * No radiolucencies greater than 2 mm in 50% or more of the cup or stem zones; * No femoral or acetabular subsidence greater than or equal to 5 mm from baseline; * No acetabular cup inclination change greater than 4 degrees from baseline.

  • Absence of revision at the 2-year follow-up visit24 months

    No reoperations that led to removal or replacement of any of the acetabular or femoral components.