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 invitationOBSERVATIONAL
Enrollment

170

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

February 5, 2027

Study Completion Date

February 4, 2030

Conditions
Knee InjuriesJoint Surface Knee Lesions
Interventions
DEVICE

Marketed Product - MP01

Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique.

PROCEDURE

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."

Trial Locations (10)

2018

AZ Monica, Antwerp

11000

"Institut za Ortopedsko hiruske Bolesti Banjica", Belgrade

11040

Sava Memorial Hospital, Belgrade

20089

Istituto Clinico Humanitas, Milan

21000

Klinika Orto MD, Novi Sad

24125

Humanitas Gavazzeni, Bergamo

300736

County Hospital Timis Othopedy and Trauma Clinic II, Timișoara

9103401

Hadassah Medical Center, Jerusalem

91942-3026

Horizon Clinical Research, La Mesa

31-826

Szpitalem Specjalistycznym im. Ludwika Rydygiera w Krakowie sp. z o.o., Krakow

All Listed Sponsors
collaborator

Cartiheal (2009) Ltd

INDUSTRY

lead

Smith & Nephew, Inc.

INDUSTRY