NCT05357378 · Hip Innovation Technology
Safety and Effectiveness of the HIT Reverse HRS
What this study is about
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
View original scientific description
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
Interventions
DEVICE
Hip Innovation Technology Reverse Hip Replacement System
Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
DEVICE
Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
Control Arm subjects will receive one of the already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. * DePuy Synthes CORAIL® or DePuy Synthes ACTIS™ Total Hip System in combination with DePuy Synthes PINNACLE™Complete Acetabular Hip System. * Zimmer Biomet Taperloc®, Zimmer Z1™ Cementless Femoral Hip Stem System or Zimmer Biomet AVENIR® Complete Hip System in combination with Zimmer Biomet G7® Acetabular System. * Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup. * Smith \& Nephew ANTHOLOGY® Total Hip System in combination with Smith \& Nephew R3® Acetabular System
Primary outcome measures
OHS of 36 or more at the 2-year follow-up visit
Time frame: 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).
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.
Time frame: 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-up
Time frame: 24 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 visit
Time frame: 24 months
No reoperations that led to removal or replacement of any of the acetabular or femoral components.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Miami, Florida
- Tampa, Florida
- Baltimore, Maryland
- Somers Point, New Jersey
- New Albany, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations