Extension Study for Participants of Previous Study MACI00206 [NCT00719576] of MACI® Implant for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01251588
First received: November 30, 2010
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

The objective of this study is to examine the 5-year efficacy and safety of Matrix-Induced Autologous Chondrocyte Implantation (MACI® Implant), compared with arthroscopic microfracture, in patients who received study treatment in Genzyme-sponsored study MACI00206 [NCT00719576] for treatment of symptomatic articular cartilage defects of the femoral condyle, including the trochlea.


Condition Intervention Phase
Articular Cartilage Defects
Biological: Matrix-Induced Autologous Chondrocyte Implant (MACI® Implant)
Procedure: Microfracture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Protocol for Participants of Genzyme-Sponsored Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of Matrix-Induced Autologous Chondrocyte Implantation (MACI® Implant) for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from MACI00206 [NCT00719576] Baseline for the patient's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational activities) scores. [ Time Frame: MACI00206 Baseline to Week 156 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from MACI00206 Baseline for the patient's KOOS Pain and Function (Sports and Recreational activities) scores [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
  • Magnetic resonance imaging (MRI) assessments of structural repair parameters [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
    • Degree of defect fill based on the thickness of repair tissue; defect fill is to be regarded as the principle MRI indicator of response to treatment
    • Degree of integration of the repair tissue with adjacent native cartilage
    • Signal intensity of the repair tissue relative to adjacent native cartilage

  • Proportion of patients who achieve at least a 10-point improvement from MACI00206 Baseline in KOOS Pain and function (sports and recreational activities) scores [ Time Frame: up to week 260 ] [ Designated as safety issue: No ]
  • The proportion of patients in each treatment group assessed as Treatment Failures [ Time Frame: up to 260 weeks ] [ Designated as safety issue: No ]
  • Average time to treatment failure [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
    the time to treatment failure will be based on the date that the physician decides that surgical re-treatment of the original index lesion is required relative to the date of the original study surgery (i.e., arthroscopy for microfracture and arthrotomy for MACI implant). Treatment failure is only determined in relation to the original treated defect(s).

  • Change from MACI00206 Baseline in the remaining 3 subscales of the KOOS instrument [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
  • Change from MACI00206 Baseline in the patient's evaluation of overall knee condition using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
  • Change from MACI00206 Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
  • Change from MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Acute Version 2.0 for the 8 subscales and the physical and mental summary components [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
  • Change from MACI00206 Baseline in the European Quality of Life 5 dimensions (EQ-5D) health state [ Time Frame: Up to 260 weeks ] [ Designated as safety issue: No ]
  • Number of participants reporting treatment-emergent adverse events (TEAEs) [ Time Frame: up to week 260 ] [ Designated as safety issue: Yes ]
  • Number of participants reporting serious adverse events (SAEs) [ Time Frame: up to week 260 ] [ Designated as safety issue: Yes ]
  • Number of participants having subsequent surgical procedures (SSPs) [ Time Frame: up to week 260 ] [ Designated as safety issue: Yes ]

Enrollment: 128
Study Start Date: December 2010
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Matrix-Induced Autologous Chondrocyte Implant (MACI® Implant) Biological: Matrix-Induced Autologous Chondrocyte Implant (MACI® Implant)
Implantation
Active Comparator: Microfracture Procedure: Microfracture
Arthroscopic Microfracture

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients that received study treatment (MACI implant or microfracture) in the MACI00206 [NCT00719576] study.

Exclusion Criteria:

N/A

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251588

Locations
Czech Republic
Urazova nemocnice v Brne
Brno, Czech Republic, 662 50
University Hospital Na Bulovce- Department of Orthopaedic Surgery Postgraduate Medical Institute
Praha 8, Czech Republic, 180 81
France
Polyclinique Saint-Roch
Montpellier Cedex 2, France, 34967
Clinique Maussins-Nollet
Paris, France, 75019
Hôpital d'instruction des Armées Robert Picqué
VILLENAVE d'ORNON cedex, France, 33882
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022 GC
University Medical Centre of Utrecht, Department of Orthopaedics
Utrecht, Netherlands, 3508 GA
Norway
St Olavs Hospital
Trondheim, Norway, 7006
Poland
Orthopaedic & Traumatology of Motor Organs, Independent Public Clinic Hospital
Bydgoszcz, Poland, 85-094
Regional Centre of Knee Surgery & Arthroscopy, Regional Hospital of Traumatologic Surgery
Piekary Slaskie, Poland, 41-940
Lekmed Medical Center
Warsow, Poland, 01-480
Sweden
Kungsbacka Närsjukhus
Kungsbacka, Sweden, 434 80
United Kingdom
University of Oxford, Nuffield Dept. of Orthopaedic Surgery
Oxford, United Kingdom, OX3 7LD
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01251588     History of Changes
Other Study ID Numbers: MACI00809, 2009-016970-33
Study First Received: November 30, 2010
Last Updated: February 11, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Netherlands: Ministry of Health, Welfare and Sport
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Sanofi:
Cartilage legions,
Symptomatic focal cartilage defects,
Microfracture,
MACI,
Autologous chondrocyte,
Trochlea

ClinicalTrials.gov processed this record on April 17, 2014