Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04325022
Registration number
NCT04325022
Ethics application status
Date submitted
25/03/2020
Date registered
27/03/2020
Date last updated
5/12/2023
Titles & IDs
Public title
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
Query!
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
Query!
Secondary ID [1]
0
0
OR3O.2019.08
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
OR3O
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Degeneration of the Hip Joint
0
0
Query!
Revision of the Hip Joint
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Survivorship of Primary Total Hip Arthroplasty (THA)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
10 years
Query!
Secondary outcome [1]
0
0
Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
up to 10 years
Query!
Secondary outcome [2]
0
0
Harris Hip Score (HHS)
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Query!
Secondary outcome [3]
0
0
Five-level EuroQol five-dimensional (EQ-5D-5L) score
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Query!
Secondary outcome [4]
0
0
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Query!
Secondary outcome [5]
0
0
Radiographic Assessment
Query!
Assessment method [5]
0
0
Assessments to be made from radiographs will include implant position, implant fixation, heterotopic ossification, radiolucencies, osteolysis, atrophy and hypertrophy
Query!
Timepoint [5]
0
0
6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Query!
Secondary outcome [6]
0
0
Safety Assessment
Query!
Assessment method [6]
0
0
All adverse events (AEs) occurring from the time of subject enrollment until study termination or study completion including intra-operative adverse events.
Query!
Timepoint [6]
0
0
Surgery, Discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Query!
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.
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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 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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/07/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/01/2037
Query!
Actual
Query!
Sample size
Target
400
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Mater Health Services - Brisbane
Query!
Recruitment hospital [2]
0
0
Calvary John James Hospital - Deakin
Query!
Recruitment hospital [3]
0
0
Eastern Health - Melbourne
Query!
Recruitment hospital [4]
0
0
Orthopaedic Research Institute of Queensland - Pimlico
Query!
Recruitment postcode(s) [1]
0
0
4101 - Brisbane
Query!
Recruitment postcode(s) [2]
0
0
2600 - Deakin
Query!
Recruitment postcode(s) [3]
0
0
3128 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
4812 - Pimlico
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Kentucky
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Nebraska
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Nevada
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Alberta
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
Ontario
Query!
Country [10]
0
0
Hong Kong
Query!
State/province [10]
0
0
Hong Kong
Query!
Country [11]
0
0
India
Query!
State/province [11]
0
0
Madhya Pradesh
Query!
Country [12]
0
0
India
Query!
State/province [12]
0
0
Pune
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Smith & Nephew, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04325022
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Ran Schwarzkopf, MD
Query!
Address
0
0
NYU Langone Health
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Maya Simons
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+18482700187
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04325022
Download to PDF