Clinical trial NCT01947374: Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures
Official title: Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tear; Knee, Cartilage, Articular
Keywords: Cartilage
Articular
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2013-09-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2.
* Signed patient informed consent.
* Agree to adhere to rehabilitation protocol.

Exclusion Criteria:

* Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
* Total meniscectomy
* Malalignment
* Evidence of osteoarthritis

Primary outcomes:
measure: MRI T2 Mapping
timeFrame: 24 months
Secondary outcomes:
measure: Clinical evaluation
timeFrame: 0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Rehabilitation
Study officials:
affiliation: INR
name: Clemente Ibarra, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: INR
name: Luis G Ibarra, M.D.
role: STUDY_CHAIR
affiliation: INR
name: Enrique Villalobos, M.D.
role: STUDY_DIRECTOR
affiliation: INR
name: Aldo F Izaguirre, M.D. M.Sc.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ibarra-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.
citation: Ibarra 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.
citation: Ibarra 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.