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

Prospective, Multi-center Study to Evaluate the Safety and Effectiveness of the OR3O™ Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures

NCT04325022•Smith & Nephew, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+7 more criteria

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.
+11 more criteria

Locations (12)

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

Key Dates

Start Date

July 27, 2020

Primary Completion Date

December 31, 2026

Completion Date

January 31, 2035

Last Updated

October 27, 2025

Enrollment

177

ACTUAL participants

Conditions

Advanced Degeneration of the Hip JointRevision of the Hip Joint

Interventions

Primary Total Hip Arthroplasty

DEVICE

Revision Total Hip Arthroplasty

DEVICE