Phase
Condition
N/ATreatment
HIT Hip Replacement System
Clinical Study ID
Ages 65-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has a non-inflammatory degenerative joint disease (NIDJD) or any of itscomposite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis,slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiringunilateral 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 discretionof the Investigator.
Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on ascale 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 theInvestigational site and to complete study procedures and questionnaires.
Exclusion
Exclusion Criteria:
Patient has had total hip replacement, hemi-arthroplasty, or fusion in either hip inthe last 12 months;
Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12months;
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 anchorageof 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 ineither leg (based on the Investigator's discretion);
Patient has a deformity of the affected limb or significant anatomic variance of theaffected hip;
Patient has an active malignancy or history of invasive malignancy within the lastfive years, with the exception of superficial basal cell carcinoma or squamous cellcarcinoma of the skin that has been definitively treated. Patients with carcinoma insitu of the uterine cervix definitively treated more than 1 year prior to enrollmentmay enter the study;
Patient has any condition which may, in the opinion of the Investigator, interferewith 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 thestudy (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 thesite of intended surgery;
Patient is currently participating in any investigational study not related to thisstudy's pre-operative or post-operative care;
Patient has any other severe acute or chronic medical condition that may interferewith 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 orosteomalacia);
Patient is currently pregnant or is planning to become pregnant.
Study Design
Study Description
Connect with a study center
Orthopaedic Innovation Centre
Winnipeg, Manitoba R2K 2M9
CanadaActive - Recruiting
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