A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.

Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003

The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.

• Prospective, randomized, active treatment-controlled, open-label multicenter study (up to 40 sites in the US and EU).
• All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Chondro-Gide® either sutured or glued or Microfracture alone.
• Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized randomization list to receive one of the following treatments: Group I: Microfracture alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane sutured (AMIC sutured)
• All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2 and 5 years).
• Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
• Measures to assess effectiveness and safety will be conducted at all follow-ups.
• Safety will be assessed by the collection of adverse events at all timepoints.

Inclusion Criteria:

• Male or female between 18 and 50
• One or two cartilage defects Grade III or IV according to Outerbridge classification
• Defect size between 2 and 10 cm2 (inclusive)
• Intact normal surrounding cartilage to suture the Chondro-Gide® membrane
• Informed consent
• Patient willing to fulfill a strict postoperative physiotherapy scheme

Exclusion Criteria:

• More than 2 defects
• Defects on both knees
• X-ray signs of osteoarthritis
• Bone lesion > 0.7 cm in the defect
• Knee instability, varus or valgus deformation, status after complete meniscus resection, status after mosaicplasty, patella dysplasia
• Rheumatoid, infectious disease
• Skin lesion on the operated knee
• Treatment with cartilage building medication
• Drug and alcohol abuse
• Chronic heart disease, endocrine or metabolic disease, Haemophilia A/B
• Pregnancy or lactation
• Collagen allergy
• Participation in other Trials