Clinical trial NCT04325022: Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survivorship of Primary Total Hip Arthroplasty (THA)
timeFrame: 2 years
Secondary outcomes:
measure: Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head)
timeFrame: up to 10 years
measure: Harris Hip Score (HHS)
timeFrame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
measure: Five-level EuroQol five-dimensional (EQ-5D-5L) score
timeFrame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
measure: Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
timeFrame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
measure: Forgotten Joint Score 12 (FJS-12)
timeFrame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Acetabular Cup Migration
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Femoral Stem Subsidence
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Osseointegration Status - Acetabular Cup
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Acetabular Cup Loosening
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Device Integrity
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Progressive Radiolucency Acetabular Zones
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Progressive Radiolucency Femoral Zones
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Osteolysis - Acetabular Cup
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Osteolysis - Femoral Stem
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Anatomic Fracture
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
measure: Radiographic Assessment - Heterotopic Ossification
timeFrame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Other outcomes:
Locations:
city: Tucker
country: United States
facility: Emory Orthopaedics and Spine Hospital
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Reno
country: United States
facility: Reno Orthopedic clinic foundation
state: Nevada
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Austin
country: United States
facility: St. David's Center for Hip and Knee Replacement
state: Texas
city: Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
city: Deakin
country: Australia
facility: Calvary John James Hospital
city: Calgary
country: Canada
facility: South Health Campus, Calgary
state: Alberta
city: London
country: Canada
facility: London Health Sciences Center Division of Orthopaedics
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: NYU Langone Health
name: Ran Schwarzkopf, MD
role: PRINCIPAL_INVESTIGATOR
References: