Safety and Effectiveness of the HIT Reverse HRS

Exclusion Criteria21

• 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.