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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Hip Joint Disease
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
- Enrollment
- 24
- Locations
- 4
- Primary Endpoint
- Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
- Status
- Terminated
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
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.
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.
Outcomes
Primary Outcomes
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
Time Frame: 12 months
Number of participants with an excellent (≥ 90) or good (80-89) Harris Hip Score at 12 months postoperative (No/Yes). The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
Secondary Outcomes
- Survivorship of the OR3O™ Dual Mobility System(6 weeks, 3 months, 6 months, and 12 months)
- Harris Hip Score (HHS)(Preoperative, 6 weeks, 6 months, and 12 months)
- EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score(Preoperative, 6 weeks, 6 months, and 12 months)
- EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score(Preoperative, 6 weeks, 6 months, and 12 months)
- Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)(Preoperative, 6 weeks, 6 months, and 12 months)
- Radiographic Assessment - Implant Position/Orientation(6 months and 12 months)
- Radiographic Assessment - Implant Subsidence/Migration(6 months and 12 months)
- Radiographic Assessment - Heterotopic Ossification(6 months and 12 months)
- Radiographic Assessment - Radiolucencies(6 months and 12 months)
- Radiographic Assessment - Osteolysis(6 months and 12 months)
- Radiographic Assessment - Implant Loosening(6 months and 12 months)
- Radiographic Assessment - Stress Shielding(6 months and 12 months)
- Radiographic Assessment - Periprosthetic Fractures(6 months and 12 months)