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ROSA Knee Intraoperative Planning Flexibility Study

Study acronym: IntraOP
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 2026 to Jan 2027 Completion date: Jan 2028 to Jan 2029v5 Show 1 more changeShow less
    • Completion date: Jan 2028 to Jan 2029
  2. Primary completion date: Jul 2025 to Jan 2026 Completion date: Jul 2027 to Jan 2028 · Site details revisedv4 Show 2 more changesShow less
    • Completion date: Jul 2027 to Jan 2028
    • Site details revised
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 25, 2023 to Jan 5, 2024 · Primary completion date: Feb 25, 2025 to Jul 2025 · Completion date: Feb 25, 2027 to Jul 2027 · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of Aug 25, 2023 to Jan 5, 2024
    • Primary completion date: Feb 25, 2025 to Jul 2025
    • Completion date: Feb 25, 2027 to Jul 2027
    • Site details revised
  4. Interventions: TKA (Device) to Total Knee Replacement (TKR) (Device)v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.
Trial Details
NCT Number NCT05966519
Lead Sponsor Zimmer Biomet
Conditions Osteo Arthritis Knee, Rheumatoid Arthritis
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov