Status:
ACTIVE_NOT_RECRUITING
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Advanced Degeneration of the Hip Joint
Revision of the Hip Joint
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility S...
Eligibility Criteria
Inclusion
- All subjects:
- Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision 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 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;
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- 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 Independent Ethical Committee (IEC) / Institutional Review Board (IRB) 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.
- Subject has all required study pre-operative and operative data available in their medical record for collection if consent is given after their THA surgery.
- Revision Subjects:
- Subject has a REDAPT™ Modular Shell implanted which does not require revision or will receive a REDAPT™ Modular Shell during revision THA.
- Subject has a S+N compatible stem which does not require revision or will receive a S+N compatible stem during revision THA.
Exclusion
- All subjects:
- 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 bodily disease(s) that may interfere with THA survival or outcome.
- Subject has life expectancy of less than 10 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 an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- 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.
- Revision Subjects:
- Subject has inadequate implant support with an increased risk of implant failure if support is not achieved, poor bone quality exists, or smaller sized implants are utilized.
- Subject needs revision of a fractured ceramic head or liner.
- Subject was already enrolled into this study as primary THA case.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2035
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT04325022
Start Date
July 27 2020
End Date
January 31 2035
Last Update
October 27 2025
Active Locations (12)
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1
University of Kentucky
Lexington, Kentucky, United States, 40508
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 69198
3
NYU Langone Health
New York, New York, United States, 10003
4
Hospital for Special Surgery
New York, New York, United States, 10021