A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.
A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.
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.
Inclusion Criteria:
Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System or single-bearing design Total Hip System in primary total hip replacement in the Investigator's judgement.
Subject is skeletally mature in the Investigator's judgement.
Subject is 18 - 80 years old (inclusive).
Subject is receiving total hip replacement for the first time on the affected hip.
Subject has any of the following conditions:
Subject provides written informed consent for study participation using an Ethical Committee (EC) approved consent form before any study procedures are performed, including pre-operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Subjects with preoperative HHS ≤ 79 (fair or worse category).
Exclusion Criteria:
Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
Subject has dysplasia of hip joint with CROWE Grade III, IV.
Subject has weak constitution or failing to endure the surgery due to other diseases of the body.
Subject has bodily disease(s) that may interfere with THA survival or outcome.
Subject has life expectancy of less than 2 years.
Subject has mental or neurological conditions which impair the subject's ability or willingness to restrict activities that may put the affected limb at risk.
Subject has physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities.
Subject has neuromuscular dysfunctions (paralysis, myolysis and abductor muscle weakness) which will cause unstable hip joint or abnormal gait after surgery.
Subject has a mental 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 has an active infection - systemic or at the site of intended surgery.
Subject has a Body Mass Index ≥ 40.0 kg/m².
Subject has a known allergy to any component of the devices used in the study.
Subject is pregnant or breast feeding.
Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation.
Subjects that are expected with poor compliance.
Subjects with complications of other diseases are limited to participate in the research, not able to comply with the follow-up or have impact on scientific integrity.
Subjects with preoperative HHS ≥ 80 (good to excellent category).
Subject has other diseases or conditions that investigator considers not appropriate to participate in the study.
Shanghai, 200011, China