By InvitationNot Applicable

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

United States, Belgium, Israel170 participantsStarted 2025-05-05

Plain-language 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).

Who can participate

Age range21 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.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).

What they're measuring

Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years

Timeframe: Baseline and 7 years

Trial details

NCT IDNCT06916728

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-02-05

View on ClinicalTrials.gov More Knee Injuries trials