NCT04941729TerminatedNot Applicable
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.
Smith & Nephew Medical (Shanghai) Ltd6 sites in 1 country24 target enrollmentStarted: June 24, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 24
- Locations
- 6
- Primary Endpoint
- Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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)
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAAdvanced Degeneration of the Hip JointRevision of the Hip JointNCT04325022Smith & Nephew, Inc.177
Completed
Not Applicable
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular CupPrimary OsteoarthritisPost-traumatic Osteoarthritis of Hip NosFemur Head NecrosisFemur Neck FractureCongenital DislocationsNCT02062450Stryker Trauma and Extremities379
Active, not recruiting
Phase 4
A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THASerum Metal Levels, Specifically Cobalt, Chromium, and TitaniumNCT03371212Rush University Medical Center52
Completed
Phase 3
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice.Head LiceNCT00301327Summers Laboratories120
Recruiting
Phase 3
A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED)Dry Eye DiseaseNCT06329791Azura Ophthalmics500