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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

NCT06916728 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2026-02-27

No results posted yet for this study

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).

Conditions

  • Knee Injuries
  • Joint 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.

Sponsors & Collaborators

  • Cartiheal (2009) Ltd

    collaborator INDUSTRY

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Samantha Andrews · Smith & Nephew, Inc.

  • Galit Reske · Smith & Nephew, Inc.

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2027-02-05
Completion
2030-02-04

Countries

  • United States
  • Belgium
  • Israel
  • Italy
  • Romania
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06916728 on ClinicalTrials.gov