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

Launched by GEISTLICH PHARMA AG · Dec 12, 2016

Keywords

ClinConnect Summary

* 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...

Gender

ALL

Eligibility criteria

• 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