Clinical trial NCT01251588: Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee
Official title: An Extension Protocol for Participants of Genzyme-Sponsored Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Articular Cartilage Defects
Keywords: Cartilage legions
Symptomatic focal cartilage defects
Microfracture
MACI
Autologous chondrocyte
Lead sponsor: Vericel Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.

Brief summary: To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.

Detailed description: This study was an open-label, multicenter extension to the SUMMIT study designed to examine the 5-year efficacy and safety of MACI compared to arthroscopic microfracture in the treatment of articular cartilage defects of the knee in participants who received study treatment in the SUMMIT study. Follow-up to 2 years post-study treatment was completed as part of the SUMMIT study. Follow-up from 3 to 5 years post-study treatment in SUMMIT was completed in this extension study.

All 144 participants who received study treatment in the SUMMIT study were eligible for enrollment into this extension study. Participants had until the end of the visit window for the last visit of this extension study (ie, Week 260 + 6 weeks) to consent to enter this extension study.

Efficacy and safety assessments were performed at scheduled visits 3, 4, and 5 years following treatment in SUMMIT (ie, at Weeks 156, 208, and 260 postarthrotomy for patients treated with MACI implant or at Weeks 156, 208, and 260 postarthroscopy for patients treated with microfracture).

Eligibility criteria: Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.

Primary outcomes:
measure: Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores.
timeFrame: MACI00206 Baseline to Week 156
Secondary outcomes:
measure: Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores
timeFrame: MACI00206 Baseline and Week 260
measure: Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill
timeFrame: Week 260
measure: Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores
timeFrame: Up to week 260
measure: The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures
timeFrame: Years 2 through 5 post treatment (MACI or microfracture)
measure: Average Time to Treatment Failure
timeFrame: Up to 260 weeks
measure: Change From MACI00206 Baseline in the Remaining 3 Subscales (Activities of Daily Living, Quality of Life, and Other Symptoms) of KOOS
timeFrame: MACI00206 Baseline and Week 260
measure: Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form
timeFrame: MACI00206 Baseline and Week 260
measure: Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the Modified Cincinnati Knee Rating System
timeFrame: MACI00206 Baseline and Week 260
measure: Change From MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Physical and Mental Component Scores
timeFrame: MACI00206 Baseline and Week 260
measure: Change From MACI00206 Baseline in the European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Score
timeFrame: MACI00206 Baseline and Week 260
measure: Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
timeFrame: Years 2 through 5 post treatment (MACI or microfracture)
measure: Number of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: Years 2 through 5 post treatment (MACI or microfracture)
measure: Number of Participants Having Subsequent Surgical Procedures (SSPs) in Target Knee
timeFrame: Years 2 through 5 post treatment (MACI or microfracture)
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Urazova nemocnice v Brne
city: Praha 8
country: Czechia
facility: University Hospital Na Bulovce- Department of Orthopaedic Surgery Postgraduate Medical Institute
city: Montpellier Cedex 2
country: France
facility: Polyclinique Saint-Roch
city: Paris
country: France
facility: Clinique Maussins-Nollet
city: VILLENAVE d'ORNON cedex
country: France
facility: Hôpital d'instruction des Armées Robert Picqué
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Utrecht
country: Netherlands
facility: University Medical Centre of Utrecht, Department of Orthopaedics
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Bydgoszcz
country: Poland
facility: Orthopaedic & Traumatology of Motor Organs, Independent Public Clinic Hospital
city: Piekary Slaskie
country: Poland
facility: Regional Centre of Knee Surgery & Arthroscopy, Regional Hospital of Traumatologic Surgery
city: Warsow
country: Poland
facility: Lekmed Medical Center
city: Kungsbacka
country: Sweden
facility: Kungsbacka Närsjukhus
city: Oxford
country: United Kingdom
facility: University of Oxford, Nuffield Dept. of Orthopaedic Surgery
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: