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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
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
10 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
Radiographic Assessment
Timepoint [5] 0 0
6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Secondary outcome [6] 0 0
Safety Assessment
Timepoint [6] 0 0
Surgery, Discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 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.

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.
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 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.

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
31/01/2037
Actual
Sample size
Target
400
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04325022
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
maya.simons@smith-nephew.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04325022