Revision of the Hip Joint Clinical Trial
— OR3OOfficial title:
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
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.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | January 31, 2037 |
| Est. primary completion date | October 31, 2036 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. Revision Subjects: - Subject has a R3™ Acetabular Shell implanted which does not require revision or will receive a R3™ Acetabular Shell or 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 proximal implant support with an increased risk of implant failure as proximal support is not achieved, poor bone quality exists, and 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Mater Health Services | Brisbane | Queensland |
| Australia | Calvary John James Hospital | Deakin | |
| Australia | Eastern Health | Melbourne | |
| Australia | Orthopaedic Research Institute of Queensland | Pimlico | |
| Canada | South Health Campus, Calgary | Calgary | Alberta |
| Canada | London Health Sciences Center Division of Orthopaedics | London | Ontario |
| Canada | St Michael's Hospital | Toronto | Ontario |
| Hong Kong | Queen Mary Hospital | Hong Kong | |
| India | AIIMS Hospital | Delhi | Madhya Pradesh |
| India | Deenanath Mangeshkar Hospital and Research Center | Pune | |
| United States | St. David's Center for Hip and Knee Replacement | Austin | Texas |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Louisville Orthopaedic Clinic | Louisville | Kentucky |
| United States | Hospital for Special Surgery | New York | New York |
| United States | Hospital for Special Surgery | New York | New York |
| United States | NYU Langone Health | New York | New York |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Reno Orthopedic clinic foundation | Reno | Nevada |
| United States | Emory Orthopaedics and Spine Hospital | Tucker | Georgia |
| United States | Wake Forest School of Medicine | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Smith & Nephew, Inc. |
United States, Australia, Canada, Hong Kong, India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survivorship of Primary Total Hip Arthroplasty (THA) | Assess long-term survivorship (10 years after device implantation) of primary THA using the OR3O™ Dual Mobility System. Survivorship is defined as no revision of any of the THA components including OR3O™ Dual Mobility System (liner and insert), acetabular shell, femoral head and femoral stem. | 10 years | |
| Secondary | Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head) | Survivorship of the following specific components will be presented individually: OR3O™Dual Mobility System, Acetabular Shell, Femoral head. The endpoint of interest is time to occurrence of a revision of the specific component due to any reason. | up to 10 years | |
| Secondary | Harris Hip Score (HHS) | The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best). | Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years | |
| Secondary | Five-level EuroQol five-dimensional (EQ-5D-5L) score | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.The endpoints on the scale are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents. |
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years | |
| Secondary | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | The HOOS JR. is a short-form survey based on the Hip Disability and Osteoarthritis Outcome Score (HOOS) that specifically focuses on the outcome after THA. HOOS JR. consists of 2 areas: pain (2 items) and function, daily living (4 items). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes - no, mild, moderate, severe, extreme) and each question gets a score from 0 to 4. An interval score from 0-100 (0 indicating total hip disability and 100 indicating perfect hip health) is calculated (15). | Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years | |
| Secondary | Radiographic Assessment | Assessments to be made from radiographs will include implant position, implant fixation, heterotopic ossification, radiolucencies, osteolysis, atrophy and hypertrophy | 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years | |
| Secondary | Safety Assessment | All adverse events (AEs) occurring from the time of subject enrollment until study termination or study completion including intra-operative adverse events. | Surgery, Discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT01655355 -
Revision of the Hip Joint - Prospective Study
|
N/A |