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Not yet recruitingNCT05651997Updated Mar 12, 2026

Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee

An interventional study of MACT and AMT in Articular Cartilage Defect, Chondral Defect and Osteochondritis, sponsored by Centre Hospitalier Universitaire Vaudois. Not yet recruiting at 2 sites in Switzerland. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
15 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Articular Cartilage Defect
  • Chondral Defect
  • Osteochondritis

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Keywords

  • Cellular therapy
  • Human articular chondrocytes
03

In context

Osteochondritis

5 studies on the registry are indexed under Osteochondritis; 3 are open to participants now.

Browse Osteochondritis studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ≤ 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

Exclusion criteria

Exclusion Criteria:

  • All inflammatory and synovial pathologies
  • Diffuse or mirror lesions
  • An unfavorable biomechanical environment
  • Obesity grade II or higher, with a >35 kg/m2
  • Active smoking/ active drug dependency (hard drugs)
  • Poor compliance
  • 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 )
  • 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 , , , syphilis.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Matrix-Assisted Autologous Chondrocytes Transplantation (MACT)

    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.

    Procedure: MACT

  • Active comparator
    The Augmented Microfracture Technique (AMT)

    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.

    Procedure: AMT

Interventions

  • ProcedureMACT

    * 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.

    Also known as: Third generation of ACI

  • ProcedureAMT

    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.

    Also known as: AMIC

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the femorotibial joint.

Other outcomes

  1. Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC)

    A score will be calculated, and it ranges from 0 (worst score) to 100 (best score).

    Time frame: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the patellofemoral and femorotibial joints.

  2. Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)

    Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage repair).

    Time frame: Up to 60 months.

  3. The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair

    MOCART scoring system is based on MRI analysis. A score in points will be calculated, and it ranges from 0 points (no repair) to 100 points (excellent cartilage defect repair)

    Time frame: Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation.

07

Study locations

2 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2022
First posted
Dec 15, 2022
StartEst.
Dec 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Jun 1, 2032
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05651997
Collaborators
Virginie PHILIPPE, Lee Ann LAURENT APPLEGATE
Responsible party
Dr. Robin Martin (Principal Investigator, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Dec 15, 2022
Start date
Dec 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2032 (estimated)
Last update
Mar 12, 2026

Study contacts

Robin MARTIN, MD
Contact
robin.martin@chuv.ch
021 314 76 79 ext. 41
Virginie PHILIPPE, Ph-D
Contact
virginie.philippe@chuv.ch
021 314 90 18 ext. 41
Robin MARTIN, MD
principal investigator · CHUV

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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