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

Launched by SMITH & NEPHEW, INC. · Mar 25, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the OR3O™ Dual Mobility System, which is a special type of hip implant designed for patients undergoing total hip replacement surgery or revision of a previous hip surgery. The goal is to determine how safe and effective this implant is over a period of ten years. If you have advanced hip joint degeneration or have had previous hip surgeries that didn’t work well, you might be eligible to participate in this study. Participants should be between 18 and 80 years old and must provide written consent to take part.

If you join the trial, you will receive the OR3O™ Dual Mobility System during your surgery, and you’ll be monitored for up to ten years to see how well the implant works and if it stays in place without complications. It’s important to know that certain health conditions, like severe bone issues or infections, may exclude you from participating. This study is currently recruiting participants, and all genders are welcome to apply. If you think you meet the criteria and are interested, you can discuss this opportunity with your doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:
• 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.