study to evaluate the safety and efficacy of or3o™ dual mobility system vs. conventional single bearing design total hip system

Conditions: Degenerative Hip Joint Disease; Rheumatoid Arthritis (RA); Femoral Neck Fractures; Avascular Necrosis of Femoral Head; Osteoarthritis (OA); Hip Dislocation; Hip Fractures

Summary: 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.


Eligibility criteria:
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: * advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis(ra); * fracture or avascular necrosis of the femoral head; * all forms of osteoarthritis(oa); * patients with hips at risk of dislocation; * femoral neck fracture or proximal hip joint fracture. * 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.: * blood supply limitations; * insufficient quantity or quality of bone support, e.g., osteoporosis, metabolic disorders which may impair bone formation, radioactive bone disease, tumor around hip joint, and osteomalacia; * infections or other conditions which may lead to increased bone resorption. * 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.

Keywords: total hip arthroplasty (tha)