Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cartilage Injury
- Sponsor
- Geistlich Pharma AG
- Enrollment
- 67
- Locations
- 7
- Primary Endpoint
- Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
* 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.
Investigators
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
Outcomes
Primary Outcomes
Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years
Time Frame: 2 years post-surgery
The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score
MRI (magnetic resonance imaging) assessment of structural repair parameters.
Time Frame: 6 months and 1,2 and 5 years post-surgery
Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).
Secondary Outcomes
- Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.(6 months and 1,2 and 5 years post-surgery)
- Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).(6 months and 1,2 and 5 years post-surgery)
- Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".(6 months and 1,2 and 5 years post-surgery)
- Adverse Events (AE) Review(5 years post-surgery)