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 | Enrolling By Invitation

• 1 other identifier: CLN-0029-1272
• Study Type: observational
• Target: 170
• Locations: 6 countries
• Sites: 8

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 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

Keywords

Knee cartilage lesions; joint surface lesions of the knee

Outcome Measures

Primary Outcomes (1)

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

  Long-term effectiveness of Marketed Product - MP01 compared to SSOC measured by change in baseline to year 7 in overall KOOS (mean of Pain, Symptoms, Quality of Life (QOL), Function in Daily Living (ADL) and Sports subscales) in subjects treated with Marketed Product - MP01 vs SSOC. Baseline is defined as the pivotal study screening visit. Overall scores are converted to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems (i.e., a lower score is a worse outcome, and high score is a better outcome).

  Baseline and 7 years

Secondary Outcomes (11)

• Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections)

  up to 10 years

• Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (including intra-articular injections)

  up to 10 years

• Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate

  up to 10 years

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

  Baseline and 7 years

• Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years

  Baseline and 10 years

Study Arms (2)

Marketed Product - MP01

Subjects who had joint surface lesions of the knee randomized to be treated with Marketed Product - MP01 in the Pivotal study.

Device: Marketed Product - MP01

Surgical Standard of Care - SSOC

Subjects who had joint surface lesions of the knee randomized to be treated with Surgical Standard of Care (SSOC) - microfracture or debridement in the Pivotal study.

Procedure: Surgical Standard of Care

Interventions

Marketed Product - MP01 DEVICE

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

Marketed Product - MP01

Surgical Standard of Care PROCEDURE

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.

Surgical Standard of Care - SSOC

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 170 subjects who had joint surface lesions of the knee, participated in the pivotal study and consent to continue follow-up will be enrolled.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cartiheal (2009) Ltd: collaborator
• Smith & Nephew, Inc.: lead

Study Sites (8)

Horizon Clinical Research

La Mesa, California, 91942-3026, United States

Location

AZ Monica

Antwerp, 2018, Belgium

Location

Hadassah Medical Center

Jerusalem, 9103401, Israel

Location

Humanitas Gavazzeni

Bergamo, 24125, Italy

Location

Istituto Clinico Humanitas

Milan, 20089, Italy

Location

County Hospital Timis Othopedy and Trauma Clinic II

Timișoara, 300736, Romania

Location

Institut za Ortopedsko hiruske Bolesti "Banjica"

Belgrade, 11000, Serbia

Location

Klinika Orto MD

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Samantha Andrews

  Smith & Nephew, Inc.

  STUDY CHAIR

• Galit Reske

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 4, 2030
• Last Updated: February 27, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); IT (2); RO (1); IL (1); US (1); SE (2)