Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

Tear; Knee, Cartilage, Articular Clinical Trial

Official title:

Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947374
• Other study ID #: 017-05-INR
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2012
• Last updated: April 11, 2017
• Start date: January 2010
• Est. completion date: January 2015

Study information

• Verified date: April 2017
• Source: Instituto Nacional de Rehabilitacion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tear; Knee, Cartilage, Articular

Intervention

Procedure:
• Matrix encapsulated chondrocyte implantation
Each implant contains 6,000,000 autologous chondrocytes.
• Microfracture awl
Is an awl that allow perforation of the subchondral bone.

Locations

Country	Name	City	State
Mexico	National Institute of Rehabilitation	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Rehabilitacion	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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. — View Citation

Ibarra-Ponce de León JC, Velasquillo-Martínez MC, Izaguirre A, Villalobos-Córdova E, Masri M, Ibarra-Ibarra LG. [Cartilage repair: cell-based techniques]. Acta Ortop Mex. 2009 Jan-Feb;23(1):38-44. Review. Spanish. — View Citation

Masri M, Lombardero G, Velasquillo C, Martínez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI T2 Mapping	Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.	24 months
Secondary	Clinical evaluation	Clinical assessment with validated knee scores, and adverse effects register are taken.	0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months

External Links

•   Official site of the INR