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Degenerative Hip Joint Disease clinical trials

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NCT ID: NCT04941729 Terminated - Hip Fractures Clinical Trials

Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System

OR3O
Start date: June 23, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets. Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative. Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery. Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation. 4 study sites in China.