Clinical trial NCT00719576: Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
Official title: A Prospective, Randomized, Open-label, Parallel-group, Multi-center Study to Demonstrate the Superiority of MACI® Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Articular Cartilage Defect
Keywords: Cartilage legions
symptomatic focal cartilage defects
microfracture
MACI
autologous chondrocyte
Lead sponsor: Vericel Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, randomized, open-label, parallel-group, multicenter study designed to investigate the outcome of MACI implant versus arthroscopic microfracture in the treatment of articular cartilage defects in the knee in patients between ages of 18 and 55 years.

All patients who meet the eligibility criteria and are considered suitable for inclusion will have a cartilage biopsy taken prior to randomization to study treatment. Eligible patients will then be randomized during the index arthroscopy procedure to receive either MACI implant or microfracture treatment.

Patients randomized to treatment with MACI implant will return within approximately 4 to 8 weeks of the index arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Patients randomized to microfracture will undergo the procedure during the index arthroscopy.

Patients will be assessed post-arthroscopy and post-arthrotomy at intervals during 2 years follow-up. Evaluations include adverse events, functional and pain outcomes, arthroscopic and histologic evaluation and magnetic resonance imaging (MRI).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Histological Evaluation of Structural Repair of Evaluable Biopsies Harvested From the Core of the Index Lesion During Arthroscopy at Week 104
timeFrame: Week 104
measure: Assessment of Defect Fill by Magnetic Resonance Imaging (MRI)
timeFrame: Week 104
measure: Response Rate Based on KOOS Pain and Function (Sports and Recreational Activities) Scores at Week 104.
timeFrame: Week 104
measure: Treatment Failure
timeFrame: Week 104
measure: Change From Baseline at Week 104 in the Remaining 3 Subscales of the KOOS Instrument (Activities of Daily Living, Knee-related Quality of Life, and Other Symptoms)
timeFrame: Baseline and Week 104
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: Week 104
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Urazova nemocnice v Brne
city: Prague
country: Czechia
facility: Fakultni Nemocnice Na Bulovce
city: Prague
country: Czechia
facility: Fakultni Nemocnice v Motole
city: Bordeaux
country: France
facility: Hopital d'instruction des armees Robert Picque
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Montpellier
country: France
facility: Polyclinique Saint-Roch
city: Paris
country: France
facility: Chirurgien Orthopediste et Traumatologue du Sport, Institut de I'Appareil Locomoteur Nollet
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki
city: Piekary Slaskie
country: Poland
facility: Regional Hospital of Traumatologic Surgery
city: Warsaw
country: Poland
facility: Center for Sports Medicine CMS
city: Warsaw
country: Poland
facility: Medical Academy Warsaw
city: Kungsbacka
country: Sweden
facility: Kungsbacka Hospital
city: Stockholm
country: Sweden
facility: Capio Artro Clinic AB
city: Epsom
country: United Kingdom
facility: The South West London Elective Orthopaedic Centre (SWLEOC)
city: Oxford
country: United Kingdom
facility: Nuffield Dept. of Orthopaedic Surgery, University of Oxford
city: Warrington
country: United Kingdom
facility: Spire Cheshire Hospital
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, Emans P, Podskubka A, Tsuchida A, Kili S, Levine D, Brittberg M; SUMMIT study group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2014 Jun;42(6):1384-94. doi: 10.1177/0363546514528093. Epub 2014 Apr 8.