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

Study acronym: OR3O
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. 2 versions Re-verified since Jun 30, 2026, no change to tracked fieldsv20-v21
  2. Primary completion date changed from estimate of Dec 31, 2026 to Feb 23, 2026v19
  3. Study sites: 13 to 12v18
  4. Study sites: 14 to 13v17
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 20 to 14
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Enrollment target: 400 to 177v15 Show 5 more changesShow less
    • Primary completion date: Oct 31, 2036 to Dec 31, 2026
    • Study completion date: Jan 31, 2037 to Jan 31, 2035
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 6 to 16
    • Site details revised at 4 of 20 sites
  2. Re-verified, no change to tracked fieldsv14
  3. Study sites: 21 to 20v13
  4. Re-verified, no change to tracked fieldsv12
  5. Site contacts updated at 2 of 21 sitesv11
  6. Study sites: 12 to 21v10
  7. Re-verified, no change to tracked fieldsv9
  8. Primary completion date: Aug 3, 2032 to Oct 31, 2036
    • Study completion date: Aug 3, 2032 to Jan 31, 2037
    v8
  9. Study sites: 8 to 12v7
  10. Study sites: 6 to 8v6
  11. Site details revised at 1 of 6 sitesv5
  12. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Primary completion date: Jan 2032 to Aug 3, 2032
    • Study sites: 4 to 6
    • Study completion date: Jul 2032 to Aug 3, 2032
    • Start date changed from estimate of Apr 2020 to Jul 27, 2020
    • Eligibility criteria shortened, about 5 words
  13. Phase: Not applicable to Not specifiedv3
  14. Secondary endpoints: details revised at 1 of 6 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04325022
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Advanced Degeneration of the Hip Joint, Revision of the Hip Joint
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov