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A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Feb 26, 2026, no change to tracked fieldsv7-v8
  2. Study sites: 10 to 8v6
  3. 3 versions Re-verified since Jul 9, 2025, no change to tracked fieldsv3-v5
  4. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Apr 2025 to May 5, 2025
    • Site contacts updated at 10 of 10 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the overall Knee Injury and Osteoarthritis Outcome Score (KOOS).
Trial Details
NCT Number NCT06916728
Lead Sponsor Smith & Nephew, Inc.
Collaborators: Cartiheal (2009) Ltd
Conditions
(from sponsor)		 Knee Injuries, Joint Surface Knee Lesions
Related terms Knee Injuries
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov