A Comparison Between the Performance of Chondrocytes Versus Microfracture Technique on Knee Symptoms (SUMMIT)
|Repair of Articular Cartilage Defects||Biological: Matrix-Induced Autologous Chondrocyte Implant (MACI) Procedure: Microfracture||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Open-label Parallel-group Multi-center Study to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACI®) Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.|
- Change from Baseline to week 104 for the patient's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational activities) scores. [ Time Frame: week 104 ]
- Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at week 104. [ Time Frame: week 104 ]Evaluation of histological data will be performed by independent central review blinded to the patient's treatment. An appropriate histological evaluation score will be used to assess the structural repair.
- MRI (magnetic resonance imaging) Assessment of structural repair parameters. [ Time Frame: At Baseline, week 52, and week 104 ]
- Degree of defect fill based on the thickness of repair tissue
- Degree of integration of the repair tissue with adjacent native cartilage
- Signal intensity of the repair tissue relative to adjacent native cartilage
- Response rate based on KOOS Pain and Function (Sports and Recreational activities) scores at week 104. [ Time Frame: week 104 ]A responder is defined as a patient with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from Baseline (Roos, 2003, Health Qual Life Outcomes).
- Treatment failure rate at week 104. [ Time Frame: week 104 ]The proportion of patients in each treatment group assessed as treatment failures.
- Change from Baseline at Week 104 in the remaining 3 subscales of the KOOS instrument [ Time Frame: week 104 ]Three subscales - other Symptoms, Knee-Related Quality of Life, Activities of Daily Living.
- Participants with Adverse Events [ Time Frame: week 104 ]
- Rate of treatment-emergent AEs.
- Rate of serious adverse events (SAEs).
- Rate of subsequent surgical procedures (SSPs).
- Change from Baseline in all 5 subscales of the KOOS instrument (i.e., Pain, other Symptoms, Knee-related Quality of Life, Activities of Daily Living, Sports/Recreation). [ Time Frame: weeks 24, 36, 52, and 78 ]
- Response rate based on KOOS Pain and Function (Sports and Recreational activities) scores [ Time Frame: weeks 24, 36, 52 and 78. ]The proportion of patients who responded to treatment
- Treatment failure rate [ Time Frame: weeks 24, 36, 52, and 78. ]The proportion of patients in each treatment group assessed as treatment failures.
- Average time to treatment failure [ Time Frame: week 104 ]The time to treatment failure will be based on the date that the surgeon 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 Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System [ Time Frame: weeks 52 and 104 ]
- Change from Baseline in the patient's evaluation of overall knee condition using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form. [ Time Frame: weeks 52 and 104 ]
- Change from Baseline in the 12-Item Short-Form Health Survey (SF-12) [ Time Frame: weeks 52 and 104 ]Acute Version 2.0 for the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health), and the physical and mental summary components.
- Change from Baseline in the European Quality of Life (EuroQOL) 5 dimensions (EQ-5D) health state. [ Time Frame: weeks 52 and 104 ]
- Macroscopic International Cartilage Repair Society (ICRS) "Cartilage Repair Assessment" score during arthroscopy at Week 104 in patients undergoing arthroscopy for harvesting of biopsy of the index lesion [ Time Frame: week 104 ]
|Study Start Date:||July 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Matrix-Induced Autologous Chondrocyte Implant
Biological: Matrix-Induced Autologous Chondrocyte Implant (MACI)
Active Comparator: Microfracture
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719576
|Urazova nemocnice v Brne|
|Brno, Czech Republic|
|Fakultni Nemocnice Na Bulovce|
|Prague, Czech Republic|
|Fakultni Nemocnice v Motole|
|Prague, Czech Republic|
|Hopital d'instruction des armees Robert Picque|
|Centre Hospitalier Lyon Sud|
|Chirurgien Orthopediste et Traumatologue du Sport, Institut de I'Appareil Locomoteur Nollet|
|Academisch Ziekenhuis Maastricht|
|St. Elisabeth Ziekenhuis|
|St Olavs Hospital|
|Regional Hospital of Traumatologic Surgery|
|Piekary Slaskie, Poland|
|Center for Sports Medicine CMS|
|Medical Academy Warsaw|
|Capio Artro Clinic AB|
|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|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|