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Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

Primary Purpose

Tear; Knee, Cartilage, Articular

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Matrix encapsulated chondrocyte implantation
Microfracture awl
Sponsored by
Instituto Nacional de Rehabilitacion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tear; Knee, Cartilage, Articular focused on measuring Cartilage, Articular

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chondrocyte implantation

Microfractures

Arm Description

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.

Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.

Outcomes

Primary Outcome Measures

MRI T2 Mapping
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.

Secondary Outcome Measures

Clinical evaluation
Clinical assessment with validated knee scores, and adverse effects register are taken.

Full Information

First Posted
February 4, 2012
Last Updated
April 11, 2017
Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
National Council of Science and Technology, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01947374
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
National Council of Science and Technology, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tear; Knee, Cartilage, Articular
Keywords
Cartilage, Articular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chondrocyte implantation
Arm Type
Experimental
Arm Description
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.
Arm Title
Microfractures
Arm Type
Experimental
Arm Description
Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.
Intervention Type
Procedure
Intervention Name(s)
Matrix encapsulated chondrocyte implantation
Intervention Description
Each implant contains 6,000,000 autologous chondrocytes.
Intervention Type
Procedure
Intervention Name(s)
Microfracture awl
Intervention Description
Is an awl that allow perforation of the subchondral bone.
Primary Outcome Measure Information:
Title
MRI T2 Mapping
Description
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Clinical evaluation
Description
Clinical assessment with validated knee scores, and adverse effects register are taken.
Time Frame
0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemente Ibarra, M.D.
Organizational Affiliation
INR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis G Ibarra, M.D.
Organizational Affiliation
INR
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Enrique Villalobos, M.D.
Organizational Affiliation
INR
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aldo F Izaguirre, M.D. M.Sc.
Organizational Affiliation
INR
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Rehabilitation
City
Mexico City
ZIP/Postal Code
14389
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
17681210
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.
Results Reference
background
PubMed Identifier
19462773
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.
Results Reference
background
PubMed Identifier
24746406
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.
Results Reference
background
PubMed Identifier
34048286
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.
Results Reference
derived
Links:
URL
http://www.inr.gob.mx
Description
Official site of the INR

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Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

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