Clinical Trial

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

Enrolling by Invitation
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Summary
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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-03-31; most recent amendment 2026-07-14.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-05-15
Trial Details
NCT Number NCT06916728
Lead Sponsor Smith & Nephew, Inc.
Collaborators: Cartiheal (2009) Ltd
Conditions Knee Injuries, Joint Surface Knee Lesions
Enrollment 170 participants
Start Date 2025-05-05
Primary Completion 2027-02-05 (estimated)
Study Completion 2030-02-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-16