Cartilage Injury, Osteochondritis Dissecans
Conditions
Keywords
microfracture, enhanced marrow stimulation, articular cartilage, Autologous Matrix-Induced Chondrogenesis, Chondro-Gide®, knee surgery, AMIC
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.
Interventions
PROCEDUREMicrofracture
Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot
DEVICEChondro-Gide sutured
Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
DEVICEChondro-Gide glued
Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy
Sponsors
Geistlich Pharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | The Change from Baseline will be evaluated. |
| 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 | The Change from Baseline will be evaluated. |
| 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 | The Change from Baseline will be evaluated. |
| Adverse Events (AE) Review | 5 years post-surgery | The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants. |
Countries
Germany
Outcome results
None listed