Articular Cartilage DefectNCT05651997
Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee
A study testing MACT and AMT in people with Articular Cartilage Defect and Chondral Defect, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
The major objective of this study is to evaluate the efficacy of the MACT versus the AMT for the treatment of large cartilage defects in patellofemoral and femorotibial injuries. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Articular Cartilage Defect, Chondral Defect, Osteochondritis
- What is being tested?
- MACT and AMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Dec 2026to 1 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged between 15-50 years
- Symptomatic chondral and osteochondral defect, grade III and IV according to the ICRS classification, and size between 2.5 and 15 cm2
- Failure of a conservative treatment
- Patient in good general condition, documented by an ASA score ≤ 2 (American Society of Anesthesiologists)
- Patient considered compliant and able to participate in rehabilitation and pre- and post-operative follow-up
- Consent to participate in the study
Who cannot join
- All inflammatory and synovial pathologies
- Diffuse or mirror lesions
- An unfavorable biomechanical environment
- Obesity grade II or higher, with a BMI>35 kg/m2
- Active smoking/ active drug dependency (hard drugs)
- Poor compliance
Show all 13Show fewer
- The patient is already part of another clinical trial that may compromise the present study
- Vulnerable populations (except minors aged 15-18 years)
- Presence of open growth plate (15-18 years)
- Pregnancy or planned pregnancy during the study (MRI-related contra-indication)
- Proven allergy to penicillin and gentamicin (for MACT group) and porcine collagen (for both groups)
- For final inclusion, an additional exclusion criteria will be assessed after randomization:
- Positive to HIV, HBV, HCV, syphilis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
Hôpital Fribourgeois- HFR
Fribourg, Canton of Fribourg, 1708
Daniel PETEK, MD, 78 709 86 04 ext. 41, daniel.petek@h-fr.ch
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Canton of Vaud, 1011
Robin MARTIN, MD, 021 314 76 79 ext. 41, robin.martin@chuv.ch
About this study
Official title: Randomized Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee: Augmented Microfracture Technique vs. 3rd Generation of ACI
The major objective of this study is to evaluate the efficacy of the MACT versus the AMT for the treatment of large cartilage defects in patellofemoral and femorotibial injuries.
Read the detailed description
Knee cartilage injuries are common, especially in young active adults, and have the potential to progress to osteoarthritis if left untreated, which would disable a large part of the population with joint functionality loss.The issue with knee cartilage remains in the fact that the tissue has very limited healing potential as it contains no blood vessels allowing a supply in cells for a proper regeneration. Many surgical techniques have been developed for cartilage repair, however, traditional methods have shown their limitations, especially in the case of large defects. More importantly, there is no consensus on novel surgical techniques. Therefore, the choice of a proper cartilage treatment becomes crucial Worldwide, because the aging population is increasing rapidly and there is a need to remain functional and independent as long as possible.
The overall objective of the present study is to compare two advanced surgical techniques for the treatment of large defects in cartilage: one technique consists of a more conventional and widely used approach, which stimulates the natural repair of the tissue by making micro-holes in the bone, allowing the recruitment cells from the underneath bone marrow and stabilize them with a membrane to repair the defect (technique called enhanced microfracture or AMT); and the other technique called MACT, consists of taking patients own cartilage cells from a small biopsy and growing them on a membrane to form a cartilage tissue in vitro, which is then implanted surgically at the location of the injury. This second technique has the advantage of cellular assistance in the surgery enabling to improve the regeneration.
The purpose of this study is to determine which technique (AMT or MACT) is the most appropriate to treat large cartilage injuries, in order to propose the best therapeutic option depending on the severity, size and location of the injury in the joint to the patient.
- Conditions
- Articular Cartilage Defect, Chondral Defect, Osteochondritis
- Being tested
- MACT, AMT
- Keywords
- Cellular therapy, Human articular chondrocytes
- Medical subject headings
- Osteochondritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACTProcedure or surgery
Also called Third generation of ACI
- A biopsy of healthy cartilage is taken from a non-weight bearing area of the knee joint during an arthroscopic procedure.
- The biopsy is processed in the GMP accredited laboratory to isolate and amplify chondrocytes.
- The cells are seeded and cultured on a collagen matrix (Chondro-Gide®, Geistlich Pharma)
- The membrane is implanted and sutured onto the injured site.
AMTProcedure or surgery
Also called AMIC
This treatment combines the microfracture procedure with the application of a bilayer matrix of porcine type I/III collagen (Chondro-Gide, Geistlich Pharma) and the supplementation of autologous bone.
| Study group | Role | What they receive |
|---|---|---|
| Matrix-Assisted Autologous Chondrocytes Transplantation (MACT) | Experimental | Matrix-Assisted Autologous Chondrocytes Transplantation (MACT, also called third generation of autologous chondrocyte implantation) is based on the use of type I/III collagen membrane as a three-dimensional structural support on which autologous articular chondrocytes are seeded and cultured to form cartilage prior to implantation. Receives: Procedure: MACT |
| The Augmented Microfracture Technique (AMT) | Active comparator | The Augmented Microfracture Technique (AMT, also called Autologous Matrix-Induced Chondrogenesis or AMIC) which is part of a therapeutic continuum, combines a microfracture treatment with the application of a type I/III collagen membrane. The principle is to cover the microfractured area with a resorbable membrane to stabilize the formed blood clot in order to increase the concentration of mesenchymal stem cells and promote their differentiation into a repaired tissue. Receives: Procedure: AMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patellofemoral joint-related function and quality-of-life are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS).
KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score). Self-assessment by the patient
Measured: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the patellofemoral joint.
Secondary outcomes (1)
Femorotibial joint-related function and quality-of-life are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS).
KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).Self-assessment by the patient
Measured: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the femorotibial joint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study startDec 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage DefectStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms: AMT and MACT
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Virginie PHILIPPE, Lee Ann LAURENT APPLEGATE
- Responsible party
- Principal investigator, Dr. Robin Martin, Centre Hospitalier Universitaire Vaudois
- Investigators
- Robin MARTIN, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651997
- Sponsor's protocol ID
- AMT_MACT_OTR
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee: Augmented Microfracture Technique vs. 3rd Generation of ACI
- ClinicalTrials.gov ID
- NCT05651997
- Acronym / sponsor ID
- AMT_MACT_OTR
- Conditions
- Articular Cartilage Defect, Chondral Defect, Osteochondritis
- Keywords
- Cellular therapy, Human articular chondrocytes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Virginie PHILIPPE, Lee Ann LAURENT APPLEGATE
- Study start
- Dec 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 15 Dec 2022 (actual)
- 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.
The major objective of this study is to evaluate the efficacy of the MACT versus the AMT for the treatment of large cartilage defects in patellofemoral and femorotibial injuries.
Detailed description
Knee cartilage injuries are common, especially in young active adults, and have the potential to progress to osteoarthritis if left untreated, which would disable a large part of the population with joint functionality loss.The issue with knee cartilage remains in the fact that the tissue has very limited healing potential as it contains no blood vessels allowing a supply in cells for a proper regeneration. Many surgical techniques have been developed for cartilage repair, however, traditional methods have shown their limitations, especially in the case of large defects. More importantly, there is no consensus on novel surgical techniques. Therefore, the choice of a proper cartilage treatment becomes crucial Worldwide, because the aging population is increasing rapidly and there is a need to remain functional and independent as long as possible.
The overall objective of the present study is to compare two advanced surgical techniques for the treatment of large defects in cartilage: one technique consists of a more conventional and widely used approach, which stimulates the natural repair of the tissue by making micro-holes in the bone, allowing the recruitment cells from the underneath bone marrow and stabilize them with a membrane to repair the defect (technique called enhanced microfracture or AMT); and the other technique called MACT, consists of taking patients own cartilage cells from a small biopsy and growing them on a membrane to form a cartilage tissue in vitro, which is then implanted surgically at the location of the injury. This second technique has the advantage of cellular assistance in the surgery enabling to improve the regeneration.
The purpose of this study is to determine which technique (AMT or MACT) is the most appropriate to treat large cartilage injuries, in order to propose the best therapeutic option depending on the severity, size and location of the injury in the joint to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms: AMT and MACT
| Arm | Type | Receives |
|---|---|---|
| Matrix-Assisted Autologous Chondrocytes Transplantation (MACT) | Experimental | Procedure: MACTMatrix-Assisted Autologous Chondrocytes Transplantation (MACT, also called third generation of autologous chondrocyte implantation) is based on the use of type I/III collagen membrane as a three-dimensional structural support on which autologous articular chondrocytes are seeded and cultured to form cartilage prior to implantation. |
| The Augmented Microfracture Technique (AMT) | Active comparator | Procedure: AMTThe Augmented Microfracture Technique (AMT, also called Autologous Matrix-Induced Chondrogenesis or AMIC) which is part of a therapeutic continuum, combines a microfracture treatment with the application of a type I/III collagen membrane. The principle is to cover the microfractured area with a resorbable membrane to stabilize the formed blood clot in order to increase the concentration of mesenchymal stem cells and promote their differentiation into a repaired tissue. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients aged between 15-50 years
- Symptomatic chondral and osteochondral defect, grade III and IV according to the ICRS classification, and size between 2.5 and 15 cm2
- Failure of a conservative treatment
- Patient in good general condition, documented by an ASA score ≤ 2 (American Society of Anesthesiologists)
- Patient considered compliant and able to participate in rehabilitation and pre- and post-operative follow-up
Key exclusion criteria (13 listed)
- All inflammatory and synovial pathologies
- Diffuse or mirror lesions
- An unfavorable biomechanical environment
- Obesity grade II or higher, with a BMI>35 kg/m2
- Active smoking/ active drug dependency (hard drugs)
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 |
|---|---|---|
| MACTAlso: Third generation of ACI* A biopsy of healthy cartilage is taken from a non-weight bearing area of the knee joint during an arthroscopic procedure. * The biopsy is processed in the GMP accredited laboratory to isolate and amplify chondrocytes. * The cells are seeded and cultured on a collagen matrix (Chondro-Gide®, Geistlich Pharma) * The membrane is implanted and sutured onto the injured site. | Procedure or surgery | Matrix-Assisted Autologous Chondrocytes Transplantation (MACT) |
| AMTAlso: AMICThis treatment combines the microfracture procedure with the application of a bilayer matrix of porcine type I/III collagen (Chondro-Gide, Geistlich Pharma) and the supplementation of autologous bone. | Procedure or surgery | The Augmented Microfracture Technique (AMT) |
Primary outcome
Patellofemoral joint-related function and quality-of-life are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the patellofemoral joint.
KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score). Self-assessment by the patient
1 secondary outcome
Femorotibial joint-related function and quality-of-life are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the femorotibial joint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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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.
Robin MARTIN, MD principal investigator
CHUV
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MACT and AMT in people with Articular Cartilage Defect and Chondral Defect, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin MARTIN, MD (021 314 76 79 ext. 41, robin.martin@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patellofemoral joint-related function and quality-of-life are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS). (time frame: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the patellofemoral joint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.