Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures
|ClinicalTrials.gov Identifier: NCT01947374|
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tear; Knee, Cartilage, Articular||Procedure: Matrix encapsulated chondrocyte implantation Procedure: Microfracture awl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.|
|Study Start Date :||January 2010|
|Primary Completion Date :||January 2015|
|Study Completion Date :||January 2015|
Experimental: Chondrocyte implantation
From a previous biopsy, articular cartilage matrix is digested and chondrocytes are cultured in 2 passages until implants with at least 6,000,000 cells are constructed. These constructus of 8 mm in diameter are implanted arthroscopically by means of biodegradable anchor (MINILOK QUICKANCHOR TM from DePuy-Mitek ) located at the defect and tied securely.
Procedure: Matrix encapsulated chondrocyte implantation
Each implant contains 6,000,000 autologous chondrocytes.
Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.
Procedure: Microfracture awl
Is an awl that allow perforation of the subchondral bone.
- MRI T2 Mapping [ Time Frame: 24 months ]Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
- Clinical evaluation [ Time Frame: 0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months ]Clinical assessment with validated knee scores, and adverse effects register are taken.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947374
|National Institute of Rehabilitation|
|Mexico City, Mexico, 14389|
|Principal Investigator:||Clemente Ibarra, M.D.||INR|
|Study Chair:||Luis G Ibarra, M.D.||INR|
|Study Director:||Enrique Villalobos, M.D.||INR|
|Study Director:||Aldo F Izaguirre, M.D. M.Sc.||INR|