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

Part of paid clinical trials in La Mesa, California.

Sponsor
Smith & Nephew, Inc.
Study ID
NCT06916728
Status
Enrolling By Invitation

Conditions

  • Joint Surface Knee Lesions
  • Knee Injuries

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
May 5, 2025
Status verified
May 2025
Primary completion
Feb 5, 2027
Completion
Feb 4, 2030

Study Design

Enrollment
170 participants (estimated)

Arms

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

Primary Outcome Measure

Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years [ Time Frame: Baseline and 7 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Horizon Clinical ResearchLa MesaCalifornia91942-3026-

Find similar trials in La Mesa, CA

By research site
Horizon Clinical Research· La Mesa, CA

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