Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA (OR3O)

December 1, 2023 updated by: Smith & Nephew, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Deakin, Australia, 2600
        • Recruiting
        • Calvary John James Hospital
        • Contact:
        • Principal Investigator:
          • Paul Smith, MD
      • Melbourne, Australia, 3128
        • Recruiting
        • Eastern Health
        • Contact:
        • Principal Investigator:
          • Sina Babazadeh, MD
      • Pimlico, Australia, 4812
        • Withdrawn
        • Orthopaedic Research Institute of Queensland
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Health Services
        • Contact:
        • Principal Investigator:
          • Simon Journeaux
        • Sub-Investigator:
          • John Radovanovic
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M127
        • Recruiting
        • South Health Campus, Calgary
        • Contact:
        • Principal Investigator:
          • Neil J White
        • Sub-Investigator:
          • James Mackenzie
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Suspended
        • London Health Sciences Center Division of Orthopaedics
      • Toronto, Ontario, Canada, M5C1R6
        • Recruiting
        • St Michael's Hospital
        • Principal Investigator:
          • Amit Atrey, MD
        • Sub-Investigator:
          • Amir Khoshbin, MD
        • Contact:
  • Hong Kong
      • Hong Kong, Hong Kong, 2255
        • Recruiting
        • Queen Mary Hospital
        • Contact:
        • Principal Investigator:
          • Henry FU, MD
  • India
      • Pune, India, 411004
        • Active, not recruiting
        • Deenanath Mangeshkar Hospital and Research Center
    • Madhya Pradesh
      • Delhi, Madhya Pradesh, India, 462020
        • Withdrawn
        • AIIMs Hospital
  • United States
    • Georgia
      • Tucker, Georgia, United States, 30084
        • Suspended
        • Emory Orthopaedics and Spine Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Active, not recruiting
        • University of Kentucky
      • Louisville, Kentucky, United States, 40207
        • Not yet recruiting
        • Louisville Orthopaedic Clinic
        • Contact:
        • Principal Investigator:
          • Alex Sweet, MD
    • Nebraska
      • Omaha, Nebraska, United States, 69198
        • Active, not recruiting
        • University of Nebraska Medical Center
    • Nevada
      • Reno, Nevada, United States, 89503
        • Recruiting
        • Reno Orthopedic clinic foundation
        • Principal Investigator:
          • Sanjai Shukla, MD
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Principal Investigator:
          • Edwin Su
        • Contact:
      • New York, New York, United States, 10003
      • New York, New York, United States, 10021
        • Withdrawn
        • Hospital for Special Surgery
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • St. David's Center for Hip and Knee Replacement
        • Contact:
        • Principal Investigator:
          • Jacob Manuel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Total Hip Arthroplasty (THA)
OR3O Dual Mobility System used in primary THA
Device: Primary Total Hip Arthroplasty
Primary Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components
Revision Total Hip Arthroplasty (THA)
OR3O Dual Mobility System used in revision THA
Device: Revision Total Hip Arthroplasty
Revision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship of Primary Total Hip Arthroplasty (THA)
Time Frame: 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head)
Time Frame: up to 10 years
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
Harris Hip Score (HHS)
Time Frame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
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
Five-level EuroQol five-dimensional (EQ-5D-5L) score
Time Frame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years

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
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
Time Frame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
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
Radiographic Assessment
Time Frame: 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
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
Safety Assessment
Time Frame: Surgery, Discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Ran Schwarzkopf, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2020

Primary Completion (Estimated)

October 31, 2036

Study Completion (Estimated)

January 31, 2037

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OR3O.2019.08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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