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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
Sponsor: Smith & Nephew, Inc.
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).
Key Details
Gender
All
Age Range
21 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
170
Start Date
2025-05-05
Completion Date
2030-02-04
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Marketed Product - MP01
Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique.
Surgical Standard of Care
As no single, current therapy could be used as a single comparator for the treatment of the knee lesions treated in the pivotal study which included focal cartilage lesions on the one hand and moderate knee osteoarthritis on the other, current general practice (e.g., SSOC: Deb and MFx) was used. Deb (SSOC) is a common orthopedic surgical procedure that removes damaged cartilage and tissue from the knee. MFx (SSOC) is another common orthopedic surgical procedure that treats knee cartilage defects by creating small holes in the bone beneath the damaged cartilage.
Locations (8)
Horizon Clinical Research
La Mesa, California, United States
AZ Monica
Antwerp, Belgium
Hadassah Medical Center
Jerusalem, Israel
Humanitas Gavazzeni
Bergamo, Italy
Istituto Clinico Humanitas
Milan, Italy
County Hospital Timis Othopedy and Trauma Clinic II
Timișoara, Romania
Institut za Ortopedsko hiruske Bolesti "Banjica"
Belgrade, Serbia
Klinika Orto MD
Novi Sad, Serbia