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

NCT04325022 | Active Not Recruiting DMC FDA Device

• 1 other identifier: OR3O.2019.08
• Study Type: observational
• Target: 177
• Locations: 4 countries
• Sites: 12

Brief 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.

Conditions

Advanced Degeneration of the Hip Joint; Revision of the Hip Joint

Keywords

OR3O; THA; Dual Mobility; hip revision; hip replacement; hip joint; hip implant

Outcome Measures

Primary Outcomes (1)

• Survivorship of Primary Total Hip Arthroplasty (THA)

  Assess survivorship of the OR3O™ Dual Mobility System at 2 years post implantation in Primary THA procedures. Survivorship is defined as no revision of the Acetabular Implant and OR3O™ Liner.

  2 years

Secondary Outcomes (16)

• Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head)

  up to 10 years

• Harris Hip Score (HHS)

  Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years

• Five-level EuroQol five-dimensional (EQ-5D-5L) score

  Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years

• Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)

  Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years

• Forgotten Joint Score 12 (FJS-12)

  Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years

Study Arms (2)

Primary Total Hip Arthroplasty (THA)

OR3O Dual Mobility System used in primary THA

Device: Primary Total Hip Arthroplasty

Revision Total Hip Arthroplasty (THA)

OR3O Dual Mobility System used in revision THA

Device: Revision Total Hip Arthroplasty

Interventions

Primary Total Hip Arthroplasty DEVICE

Primary Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components

Primary Total Hip Arthroplasty (THA)

Revision Total Hip Arthroplasty DEVICE

Revision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components

Revision Total Hip Arthroplasty (THA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator's judgement

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:

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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (12)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 69198, United States

Location

NYU Langone Health

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

St. David's Center for Hip and Knee Replacement

Austin, Texas, 78705, United States

Location

Mater Health Services

Brisbane, Queensland, 4101, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Calvary John James Hospital

Deakin, 2600, Australia

Location

South Health Campus, Calgary

Calgary, Alberta, T3M127, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5C1R6, Canada

Location

Queen Mary Hospital

Hong Kong, 2255, Hong Kong

Location

Study Officials

• Ran Schwarzkopf, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: July 27, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2035
• Last Updated: October 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

HK (1); AU (3); US (6); CA (2)