Clinical trial Recruiting at 1 site Interventional Ages 65 to 79

Evaluation of a new hip replacement system for patients with hip osteoarthritis

Official title: A Multi-Center Prospective Study of the Hip Innovation Technology (HIT) Hip Replacement System in Primary Total Hip Arthroplasty

Run by Hip Innovation Technology · NCT02836262 · Data updated 2026-11-12

This study is testing a new hip replacement system to see if it helps people with hip osteoarthritis feel better and recover safely after surgery.

Quick facts

Study typeInterventional
Ages65 Years to 79 Years
SexAll
Enrollment100 (estimated)
SponsorHip Innovation Technology
Industry-sponsored
Locations1 site (Winnipeg, Manitoba)
StatusRecruiting
StartedAugust 25, 2017
Main results expectedSeptember 16, 2029
Study endsSeptember 16, 2032
Registry record updatedSeptember 21, 2026
Trial IDNCT02836262 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 65 to 79 with non-inflammatory degenerative joint disease requiring unilateral primary total hip replacement.

Probably not a fit

Patients who have had a hip replacement or fusion in the last 12 months will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of the HIT Hip Replacement System (HHRS) in patients undergoing total hip arthroplasty due to osteoarthritis. The HHRS is a Metal-on-Polyethylene hip prosthesis designed to facilitate bone in-growth and secure fixation. Effectiveness will be assessed through patient-reported outcomes, clinical evaluations, and radiologic assessments, while safety will be monitored by tracking device-related adverse events. Participants will be followed up to ensure comprehensive data collection on the device's performance.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and quality of life for patients undergoing hip replacement surgery.

How similar studies have gone: Other studies have shown success with similar hip replacement systems, indicating potential for positive outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patient has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement.
* Age between 65 and 79 years (inclusive) at the time of enrollment.
* Patient is a suitable candidate for primary total hip replacement at the discretion of the Investigator.
* Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst)
* Signed and dated informed consent document.
* 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 had total hip replacement, hemi-arthroplasty, or fusion in either hip in the last 12 months;
* Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12 months;
* Patient has a known allergy to any component of the study device;
* Patient has a history of active sepsis in the joint;
* Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are 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 discretion);
* 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 five years, with the exception of 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 any condition which may, in the opinion of the Investigator, interfere with the total hip replacement survival or patient outcomes (e.g. Paget's disease, Charcot's disease);
* Patient has rheumatoid arthritis or other autoimmune condition that affect joints (e.g. Lupus Arthritis);
* Patient has any condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion);
* Body Mass Index (BMI) of 40 or more;
* Patient has an active infection (e.g. hepatitis, AIDS, ARC) - systemic or at the site of intended surgery;
* Patient is currently participating in any investigational study not related to this study's pre-operative or post-operative care;
* Patient has any other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the Investigator, which would make the patient inappropriate for entry into this study;
* Patient has a history of metabolic bone disease (e.g. Paget's disease or osteomalacia);
* Patient is currently pregnant or is planning to become pregnant.

Where it's running

  • Orthopaedic Innovation Centre
    Winnipeg, Manitoba, Canada
    Recruiting

Study contacts

  • Principal investigator: Thomas Turgeon, MD — Orthopaedic Innovation Centre
  • Study coordinator: Linda Braddon, PhD
  • Email: LGB@SecureBME.com
  • Phone: 770-837-2681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.