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

Status: Active_not_recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

∙ 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.

Locations
United States
Kentucky
University of Kentucky
Lexington
North Carolina
Wake Forest School of Medicine
Winston-salem
Nebraska
University of Nebraska Medical Center
Omaha
New York
Hospital for Special Surgery
New York
NYU Langone Health
New York
Texas
St. David's Center for Hip and Knee Replacement
Austin
Other Locations
Australia
Mater Health Services
Brisbane
Calvary John James Hospital
Deakin
Royal Perth Hospital
Perth
Canada
South Health Campus, Calgary
Calgary
St Michael's Hospital
Toronto
Hong Kong Special Administrative Region
Queen Mary Hospital
Hong Kong
Time Frame
Start Date: 2020-07-27
Completion Date: 2035-01-31
Participants
Target number of participants: 177
Treatments
Primary Total Hip Arthroplasty (THA)
OR3O Dual Mobility System used in primary THA
Revision Total Hip Arthroplasty (THA)
OR3O Dual Mobility System used in revision THA
Related Therapeutic Areas
Sponsors
Leads: Smith & Nephew, Inc.

This content was sourced from clinicaltrials.gov