Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures
Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.
1 other identifier
interventional
48
1 country
1
Brief Summary
This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. Eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. Those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. The patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. Both groups will have the same rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 12, 2017
April 1, 2017
5 years
February 4, 2012
April 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRI T2 Mapping
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
24 months
Secondary Outcomes (1)
Clinical evaluation
0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months
Study Arms (2)
Chondrocyte implantation
EXPERIMENTALFrom 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.
Microfractures
EXPERIMENTALSubchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.
Interventions
Each implant contains 6,000,000 autologous chondrocytes.
Eligibility Criteria
You may qualify if:
- Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2.
- Signed patient informed consent.
- Agree to adhere to rehabilitation protocol.
You may not qualify if:
- Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
- Total meniscectomy
- Malalignment
- Evidence of osteoarthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Rehabilitation
Mexico City, 14389, Mexico
Related Publications (4)
Masri M, Lombardero G, Velasquillo C, Martinez V, Neri R, Villegas H, Ibarra C. Matrix-encapsulation cell-seeding technique to prevent cell detachment during arthroscopic implantation of matrix-induced autologous chondrocytes. Arthroscopy. 2007 Aug;23(8):877-83. doi: 10.1016/j.arthro.2007.05.010.
PMID: 17681210BACKGROUNDIbarra-Ponce de Leon JC, Velasquillo-Martinez MC, Izaguirre A, Villalobos-Cordova E, Masri M, Ibarra-Ibarra LG. [Cartilage repair: cell-based techniques]. Acta Ortop Mex. 2009 Jan-Feb;23(1):38-44. Spanish.
PMID: 19462773BACKGROUNDIbarra C, Izaguirre A, Villalobos E, Masri M, Lombardero G, Martinez V, Velasquillo C, Meza AO, Guevara V, Ibarra LG. Follow-up of a new arthroscopic technique for implantation of matrix-encapsulated autologous chondrocytes in the knee. Arthroscopy. 2014 Jun;30(6):715-23. doi: 10.1016/j.arthro.2014.02.032. Epub 2014 Apr 18.
PMID: 24746406BACKGROUNDIbarra C, Villalobos E, Madrazo-Ibarra A, Velasquillo C, Martinez-Lopez V, Izaguirre A, Olivos-Meza A, Cortes-Gonzalez S, Perez-Jimenez FJ, Vargas-Ramirez A, Franco-Sanchez G, Ibarra-Ibarra LG, Sierra-Suarez L, Almazan A, Ortega-Sanchez C, Trueba C, Martin FB, Arredondo-Valdes R, Chavez-Arias D. Arthroscopic Matrix-Assisted Autologous Chondrocyte Transplantation Versus Microfracture: A 6-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2021 Jul;49(8):2165-2176. doi: 10.1177/03635465211010487. Epub 2021 May 28.
PMID: 34048286DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr./Study Director
Study Record Dates
First Submitted
February 4, 2012
First Posted
September 20, 2013
Study Start
January 1, 2010
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 12, 2017
Record last verified: 2017-04