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

Launched by SMITH & NEPHEW, INC. · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called MP01 for knee injuries, specifically joint surface lesions, and comparing it to the current standard surgical care. The goal is to gather information about how effective and safe MP01 is over a long period, specifically over 10 years. The researchers want to see if patients using MP01 continue to have better results in terms of knee health and quality of life, as measured by a common scoring system, even after 7 years.

To join the study, participants must have previously taken part in a related study and be able to follow up regularly. They also need to provide consent to participate. However, individuals who have had certain knee surgeries, have undergone chemotherapy recently, or are involved in other knee-related clinical trials won't be eligible. The trial is not yet recruiting participants, but it will include people of all genders aged between 18 and 80. If you join, you can expect regular check-ins to monitor your progress and help researchers learn more about the long-term effects of MP01.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participated in the pivotal study.
• • 2. Must be physically and mentally willing and able to comply with the follow-up schedule.
• • 3. Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).
• Exclusion Criteria:
• • 1. Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
• • 2. Chemotherapy in the past 12 months.
• • 3. Participation in other clinical trials involving knee procedures.
• • 4. 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).