CompletedPhase 3

Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee

Czechia, France144 participantsStarted 2008-07

Plain-language summary

The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement Exclusion Criteria: * Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin * Severe osteoarthritis of the knee * Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders * Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.

What they're measuring

Change From Baseline to Week 104 for the Participant's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational Activities) Scores.

Timeframe: Baseline and Week 104

Trial details

NCT IDNCT00719576

SponsorVericel Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

Results submitted2017-01-12

View on ClinicalTrials.gov More Articular Cartilage Defect trials