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

Conditions studied: Knee Injuries, Joint Surface Knee Lesions

In brief

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 facts

Study ID

NCT06916728

Run by

Smith & Nephew, Inc.

People needed

170

Starts

2025-05-05

Expected to finish

2030-02-04

Last updated by the study team

2026-07-16

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participated in the pivotal study.
• Must be physically and mentally willing and able to comply with the follow-up schedule.
• Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).

You may not qualify if…

• Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
• Chemotherapy in the past 12 months.
• Participation in other clinical trials involving knee procedures.
• Vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).

Where it is running

• 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

Full record on ClinicalTrials.gov

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