Safety and Effectiveness Study of OR3Oâ„¢ Dual Mobility System in THA (NCT04325022) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness Study of OR3Oâ„¢ Dual Mobility System in THA
United States177 participantsStarted 2020-07-27
Plain-language summary
The purpose of this study is to assess the safety and effectiveness of the OR3Oâ„¢ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3Oâ„¢ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
All subjects:
* Subject is a suitable candidate for implanting the OR3Oâ„¢ 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 whi…
What they're measuring
1
Survivorship of Primary Total Hip Arthroplasty (THA)