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

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 65 Years to 79 Years
• Sex: All
• Sponsor: Hip Innovation Technology (industry)
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT02836262 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility 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 this trial is running

Winnipeg, Manitoba

• Orthopaedic Innovation Centre — Winnipeg, Manitoba, Canada (RECRUITING)

Study contacts

• Principal investigator: Thomas Turgeon, MD — Orthopaedic Innovation Centre
• Study coordinator: Linda Braddon, PhD

Conditions: Osteoarthritis of Hip