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New hip replacement device put to the test in 288-Patient trial

NCT ID NCT05357378

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new hip replacement system called the HIT Reverse Hip Replacement System. It is for people aged 50 to 75 who need a total hip replacement due to arthritis, joint damage, or other conditions. The goal is to see if the new system is as safe and effective as standard hip replacements by measuring pain, function, and implant stability over two years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Jul 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health Hospital, Carrollwood

    RECRUITING

    Tampa, Florida, 33614, United States

  • Division of Orthopaedic Surgery

    RECRUITING

    Somers Point, New Jersey, 08244, United States

  • JIS Orthopedics

    RECRUITING

    New Albany, Ohio, 43054, United States

  • LifeBridge Health Rubin Institute for Advanced Orthopedics

    TERMINATED

    Baltimore, Maryland, 21215, United States

  • Miami Institute for Joint Reconstruction

    RECRUITING

    Miami, Florida, 33186, United States

  • Tampa General Health / Florida Orthopedic Institute

    RECRUITING

    Tampa, Florida, 33615, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.