SUMMIT Extension Study

• Conditions: Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea.Osteochondritis dissecans lesions that do not require a bone graft.; MedDRA version: 14.1Level: LLTClassification code 10031231Term: Osteochondritis dissecansSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.1Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2009-016970-33-NL
• Lead Sponsor: Genzyme Europe BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-29
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Patients must meet the following criteria to participate in this extension study:
1. Received study treatment (MACI implant or microfracture) in the MACI00206 study.
2. Provides written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria, not applicable for this extension study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified