Status:
ENROLLING_BY_INVITATION
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
Lead Sponsor:
Smith & Nephew, Inc.
Collaborating Sponsors:
Cartiheal (2009) Ltd
Conditions:
Knee Injuries
Joint Surface Knee Lesions
Eligibility:
All Genders
21-75 years
Brief 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 Produc...
Detailed Description
This is a post approval, multicenter, prospective, comparative, non blinded 10-year follow-up observational study of Marketed Product - MP01 vs SSOC used for the treatment of joint surface lesions of ...
Eligibility Criteria
Inclusion
- 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
- Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.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).
Key Trial Info
Start Date :
May 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 4 2030
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06916728
Start Date
May 5 2025
End Date
February 4 2030
Last Update
November 14 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Horizon Clinical Research
La Mesa, California, United States, 91942-3026
2
AZ Monica
Antwerp, Belgium, 2018
3
Hadassah Medical Center
Jerusalem, Israel, 9103401
4
Humanitas Gavazzeni
Bergamo, Italy, 24125