Clinical evaluation of of osteochondral regeneration using silk fibroin and collagen scaffolds
Phase 1
Recruiting
- Conditions
- Osteochondral defects.
- Registration Number
- IRCT2017062434731N1
- Lead Sponsor
- Avicenna Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
female or male; within the age range of 18 to 65 years; symptomatic osteochondral lesion of the medial or lateral femoral condyles with ICRS grade 3-4 lesion.
Exclusion Criteria
meniscus removal with surgical treatment; knee non corrected instability; diagnosis with metastatic diseases or malignant diseases; pregnancy or breast feeding, history of neurological disease; history of endocrinological disorders such as diabetes; history of pulmonary heart diseases; infectious diseases such as hepatitis B and C, HIV and history of allergic diseases.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiological and Clinical Studies. Timepoint: Before intervention and 6 months and 1 year after intervention. Method of measurement: Radiographic images.;MRI studies. Timepoint: Before intervention and 6 months and 1 year after intervention. Method of measurement: MRI results.
- Secondary Outcome Measures
Name Time Method Pain in the surgical area. Timepoint: after intervention. Method of measurement: Based on available evidence.