Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA

Running, not enrolling

Conditions studied: Advanced Degeneration of the Hip Joint, Revision of the Hip Joint

In brief

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 System over a ten year period. Survivorship of THA will be assessed up to ten years.

Key facts

Study ID

NCT04325022

Run by

Smith & Nephew, Inc.

People needed

177

Starts

2020-07-27

Expected to finish

2035-01-31

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• NYU Langone Health — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• St. David's Center for Hip and Knee Replacement — Austin, Texas, United States
• Mater Health Services — Brisbane, Queensland, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• Calvary John James Hospital — Deakin, Australia
• South Health Campus, Calgary — Calgary, Alberta, Canada
• St Michael's Hospital — Toronto, Ontario, Canada
• Queen Mary Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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