Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
NCT ID: NCT00719576
Last Updated: 2021-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
144 participants
INTERVENTIONAL
2008-07-31
2012-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MACI
autologous cultured chondrocytes on porcine collagen membrane
autologous cultured chondrocytes on porcine collagen membrane
Implantation via mini-arthrotomy
Microfracture
Microfracture
Microfracture
Microfracture performed by arthroscopic surgery
Interventions
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autologous cultured chondrocytes on porcine collagen membrane
Implantation via mini-arthrotomy
Microfracture
Microfracture performed by arthroscopic surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Vericel Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Urazova nemocnice v Brne
Brno, , Czechia
Fakultni Nemocnice Na Bulovce
Prague, , Czechia
Fakultni Nemocnice v Motole
Prague, , Czechia
Hopital d'instruction des armees Robert Picque
Bordeaux, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Polyclinique Saint-Roch
Montpellier, , France
Chirurgien Orthopediste et Traumatologue du Sport, Institut de I'Appareil Locomoteur Nollet
Paris, , France
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
St Olavs Hospital
Trondheim, , Norway
Szpital Uniwersytecki
Bydgoszcz, , Poland
Regional Hospital of Traumatologic Surgery
Piekary Śląskie, , Poland
Center for Sports Medicine CMS
Warsaw, , Poland
Medical Academy Warsaw
Warsaw, , Poland
Kungsbacka Hospital
Kungsbacka, , Sweden
Capio Artro Clinic AB
Stockholm, , Sweden
The South West London Elective Orthopaedic Centre (SWLEOC)
Epsom, , United Kingdom
Nuffield Dept. of Orthopaedic Surgery, University of Oxford
Oxford, , United Kingdom
Spire Cheshire Hospital
Warrington, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2006-004817-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MACI00206
Identifier Type: -
Identifier Source: org_study_id
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