CRC_201 ODH 86
OXINIUM◊ DH Hip A Multi-Center, Randomized Controlled Study of Efficacy and Safety of the OXINIUM◊ DH Total Hip Replacement System in Subjects With Non-Inflammatory Arthritis
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 enrolled Subjects for 730 days for the primary endpoint analysis and 10 years (extended follow-up) 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.
Key Eligibility Criteria:
Age between 22 and 79 years, inclusive;
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 willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
Bill Huang, M.D.
Smith & Nephew, Inc