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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04325022




Registration number
NCT04325022
Ethics application status
Date submitted
25/03/2020
Date registered
27/03/2020

Titles & IDs
Public title
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
Scientific 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
Secondary ID [1] 0 0
OR3O.2019.08
Universal Trial Number (UTN)
Trial acronym
OR3O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Degeneration of the Hip Joint 0 0
Revision of the Hip Joint 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Primary Total Hip Arthroplasty
Treatment: Devices - Revision Total Hip Arthroplasty

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


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

Treatment: Devices: Revision Total Hip Arthroplasty
Revision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survivorship of Primary Total Hip Arthroplasty (THA)
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head)
Timepoint [1] 0 0
up to 10 years
Secondary outcome [2] 0 0
Harris Hip Score (HHS)
Timepoint [2] 0 0
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [3] 0 0
Five-level EuroQol five-dimensional (EQ-5D-5L) score
Timepoint [3] 0 0
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Secondary outcome [4] 0 0
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
Timepoint [4] 0 0
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Secondary outcome [5] 0 0
Forgotten Joint Score 12 (FJS-12)
Timepoint [5] 0 0
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [6] 0 0
Radiographic Assessment - Acetabular Cup Migration
Timepoint [6] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [7] 0 0
Radiographic Assessment - Femoral Stem Subsidence
Timepoint [7] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [8] 0 0
Radiographic Assessment - Osseointegration Status - Acetabular Cup
Timepoint [8] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [9] 0 0
Radiographic Assessment - Acetabular Cup Loosening
Timepoint [9] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [10] 0 0
Radiographic Assessment - Device Integrity
Timepoint [10] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [11] 0 0
Radiographic Assessment - Progressive Radiolucency Acetabular Zones
Timepoint [11] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [12] 0 0
Radiographic Assessment - Progressive Radiolucency Femoral Zones
Timepoint [12] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [13] 0 0
Radiographic Assessment - Osteolysis - Acetabular Cup
Timepoint [13] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [14] 0 0
Radiographic Assessment - Osteolysis - Femoral Stem
Timepoint [14] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [15] 0 0
Radiographic Assessment - Anatomic Fracture
Timepoint [15] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [16] 0 0
Radiographic Assessment - Heterotopic Ossification
Timepoint [16] 0 0
6 weeks, 1 year, 2 years, 5 years, and 10 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2035
Actual
Sample size
Target
177
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Health Services - Brisbane
Recruitment hospital [2] 0 0
Calvary John James Hospital - Deakin
Recruitment hospital [3] 0 0
Eastern Health - Melbourne
Recruitment hospital [4] 0 0
Orthopaedic Research Institute of Queensland - Pimlico
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
2600 - Deakin
Recruitment postcode(s) [3] 0 0
3128 - Melbourne
Recruitment postcode(s) [4] 0 0
4812 - Pimlico
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Hong Kong
State/province [10] 0 0
Hong Kong
Country [11] 0 0
India
State/province [11] 0 0
Madhya Pradesh
Country [12] 0 0
India
State/province [12] 0 0
Pune

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ran Schwarzkopf, MD
Address 0 0
NYU Langone Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maya Simons
Address 0 0
Country 0 0
Phone 0 0
+18482700187
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04325022