New hip replacement device put to the test in 288-Patient trial
NCT ID NCT05357378
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Avascular necrosis of hip are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGTampa, Florida, 33614, United States
-
Division of Orthopaedic Surgery
RECRUITINGSomers Point, New Jersey, 08244, United States
-
JIS Orthopedics
RECRUITINGNew Albany, Ohio, 43054, United States
-
LifeBridge Health Rubin Institute for Advanced Orthopedics
TERMINATEDBaltimore, Maryland, 21215, United States
-
Miami Institute for Joint Reconstruction
RECRUITINGMiami, Florida, 33186, United States
-
Tampa General Health / Florida Orthopedic Institute
RECRUITINGTampa, Florida, 33615, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which anesthesia gets joint replacement patients moving sooner?
- Can a cementless hip stem hold up in asian patients?
- Physical therapy may unlock lasting activity for older adults with joint pain
- Can navigation make hip replacements more precise?
- Can sleep coaching speed recovery after joint replacement?
- Can hip replacement restore steady footing? a new study investigates