New hip implant aims to cut repeat surgeries
NCT ID NCT04325022
First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This study is testing a new hip implant called the OR3O Dual Mobility System in 177 people who need hip replacement surgery. The goal is to see if the implant is safe and lasts longer without needing another surgery. Researchers will follow participants for up to 10 years to check how well the implant holds up.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OR3O Dual Mobility hip implant (a medical device)
- What this could lead to
- If successful, this could provide a more durable hip replacement option that reduces the need for repeat surgeries.
- What could go wrong
- This is an early-stage study with only 177 participants, and long-term results are not yet available. Implants can fail or cause complications like infection or dislocation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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177 people
The number who actually took part.
- Started
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Jul 2020
- Expected to finish
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Jan 2035
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator's judgement
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Calvary John James Hospital
Deakin, 2600, Australia
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Hospital for Special Surgery
New York, New York, 10021, United States
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Mater Health Services
Brisbane, Queensland, 4101, Australia
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NYU Langone Health
New York, New York, 10003, United States
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Queen Mary Hospital
Hong Kong, 2255, Hong Kong
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Royal Perth Hospital
Perth, Western Australia, 6000, Australia
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South Health Campus, Calgary
Calgary, Alberta, T3M127, Canada
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St Michael's Hospital
Toronto, Ontario, M5C1R6, Canada
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St. David's Center for Hip and Knee Replacement
Austin, Texas, 78705, United States
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University of Kentucky
Lexington, Kentucky, 40508, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 69198, United States
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Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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