OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study

A Multi-Center, Randomized Controlled Study of Efficacy and Safety of the OXINIUM◊ DH Total Hip Replacement System in Subjects With Non-Inflammatory Arthritis

The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation

This is a prospective, multi-center, interventional, randomized controlled study to investigate the safety and efficacy of the OXINIUM◊ DH Hip System (Smith & Nephew, Inc., Memphis, TN, USA). The study will follow all enrolled Subjects for 3 years and investigational Subjects for 10 years (primary safety endpoint) in total. Subjects meeting inclusion and exclusion criteria will receive THA and will be randomized to receive implantation of the Investigational or Control Device. The post-operative rehabilitation will be per standard of care at the treating institution. Up to 20 US and 10 out-of-US (OUS) enrolling investigational sites will participate in this study.

Inclusion Criteria:

• Age between 22 and 79 years, inclusive;
• Subject is skeletally mature in Investigator's judgment;
• Subject has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement;
• Preoperative (within 28 days prior to the surgery) total Harris Hip Score of less than 70;
• Subject is a suitable candidate for primary total hip replacement at the discretion of the investigator;
• Subject has given consent to participate in the study after the nature, scope, and possible consequences of the study have been explained in an understandable form;
• Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.

Exclusion Criteria:

• Subject has had a previous total hip replacement, hemi-arthroplasty, or fusion in either hip;
• Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations in the other (not study) hip;
• Subject has a known allergy to any component of the devices used in the study;
• Subject with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible;
• Subject with total or partial absence of the muscular or ligamentous apparatus of the hip joint to be operated;
• Subject has a congenital disorder or deformity of the affected limb or significant anatomic variance of the affected hip (based on Investigator's discretion);
• Subject 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.
• Subjects with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study;
• Subject has rheumatoid arthritis;
• Subject has a Body Mass Index > 40;
• Subject has an active infection (e.g. hepatitis, Acquired Immunodeficiency Syndrome, AIDS related Complex) - systemic or at the site of intended surgery;
• Subject has contralateral lower extremity condition causing abnormal ambulation and noncompliance with rehabilitation;
• Prior proximal femur fracture and/or presence of malunion, nonunion, and the surgical side;
• Subject has conditions that may interfere with THA survival or outcome (e.g., Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes defined by HgbA1c > 7%, or neuromuscular disease);
• Subject has systemic steroid therapy with 1 month prior to surgery;
• Subject is on drug therapy for the index hip with intra-articular corticosteroid therapy or any intra-articular therapy within 3 months of enrollment into the study;
• Subject has a life expectancy less than 10 years;
• Subject is female and of child bearing age who is currently pregnant or not using contraception;
• Subject has known moderate to severe renal insufficiency;
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse;
• Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation;
• Subject is unable, unwilling, or in the Investigator's opinion unlikely to return for or participate in follow-up visits at the investigational site;
• Subject is facing current or impending incarceration.