Tear; Knee, Cartilage, ArticularPhase 3NCT01947374
Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures
A Phase 3 study testing Matrix encapsulated chondrocyte implantation and Microfracture awl in people with Tear; Knee, Cartilage, Articular, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tear; Knee, Cartilage, Articular
- What is being tested?
- Matrix encapsulated chondrocyte implantation and Microfracture awl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2010to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2.
- Signed patient informed consent.
- Agree to adhere to rehabilitation protocol.
Who cannot join
- Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
- Total meniscectomy
- Malalignment
- Evidence of osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.
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.
- Conditions
- Tear; Knee, Cartilage, Articular
- Being tested
- Matrix encapsulated chondrocyte implantation, Microfracture awl
- Keywords
- Cartilage, Articular
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix encapsulated chondrocyte implantationProcedure or surgery
Each implant contains 6,000,000 autologous chondrocytes.
Microfracture awlProcedure or surgery
Is an awl that allow perforation of the subchondral bone.
| Study group | Role | What they receive |
|---|---|---|
| Chondrocyte implantation | Experimental | 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. Receives: Procedure: Matrix encapsulated chondrocyte implantation |
| Microfractures | Experimental | Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area. Receives: Procedure: Microfracture awl |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI T2 Mapping
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
Measured: 24 months
Secondary outcomes (1)
Clinical evaluation
Clinical assessment with validated knee scores, and adverse effects register are taken.
Measured: 0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tear; Knee, Cartilage, ArticularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Aldo Izaguirre, Instituto Nacional de Rehabilitacion
- Investigators
- Clemente Ibarra, M.D., Principal investigator, INRLuis G Ibarra, M.D., Study chair, INREnrique Villalobos, M.D., Study director, INRAldo F Izaguirre, M.D. M.Sc., Study director, INR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947374
- Sponsor's protocol ID
- 017-05-INR
- Status last verified
- Apr 2017
- First submitted
- 4 Feb 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17681210Ibarra-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.
PubMed 19462773Ibarra 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.
PubMed 24746406Ibarra 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.
PubMed 34048286
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT01947374
- Acronym / sponsor ID
- 017-05-INR
- Conditions
- Tear; Knee, Cartilage, Articular
- Keywords
- Cartilage, Articular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chondrocyte implantation | Experimental | Procedure: Matrix encapsulated chondrocyte implantationFrom 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 | Experimental | Procedure: Microfracture awlSubchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2.
- Signed patient informed consent.
- Agree to adhere to rehabilitation protocol.
Key exclusion criteria (4 listed)
- Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
- Total meniscectomy
- Malalignment
- Evidence of osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matrix encapsulated chondrocyte implantationEach implant contains 6,000,000 autologous chondrocytes. | Procedure or surgery | Chondrocyte implantation |
| Microfracture awlIs an awl that allow perforation of the subchondral bone. | Procedure or surgery | Microfractures |
Primary outcome
MRI T2 Mapping
Time frame: 24 months
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
1 secondary outcome
Clinical evaluation
Time frame: 0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Background: PubMed 17681210Masri 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.
- Background: PubMed 19462773Ibarra-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.
- Background: PubMed 24746406Ibarra 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.
- Derived from this study: PubMed 34048286Ibarra 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.
- Official site of the INRLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemente Ibarra, M.D. principal investigator
INR
Luis G Ibarra, M.D. study chair
INR
Enrique Villalobos, M.D. study director
INR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Matrix encapsulated chondrocyte implantation and Microfracture awl in people with Tear; Knee, Cartilage, Articular, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI T2 Mapping (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947374, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.