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

NCT05651997 | Not Yet Recruiting

• 1 other identifier: AMT_MACT_OTR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Articular Cartilage Defect; Chondral Defect; Osteochondritis

Keywords

Cellular therapy; Human articular chondrocytes

Outcome Measures

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

  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).

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

Other Outcomes (3)

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

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

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

  Up to 60 months.

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

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

Study Arms (2)

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.

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.

Procedure: AMT

Interventions

MACT PROCEDURE

* 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

Matrix-Assisted Autologous Chondrocytes Transplantation (MACT)

AMT PROCEDURE

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

The Augmented Microfracture Technique (AMT)

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• \- Positive to HIV, HBV, HCV, syphilis.

Sponsors & Collaborators

• Lee Ann LAURENT APPLEGATE: collaborator
• Virginie PHILIPPE: collaborator
• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (2)

Hôpital Fribourgeois- HFR

Fribourg, Canton of Fribourg, 1708, Switzerland

Location

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Osteochondritis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Cartilage Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robin MARTIN, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin MARTIN, MD

CONTACT

021 314 76 79; robin.martin@chuv.ch

Virginie PHILIPPE, Ph-D

CONTACT

021 314 90 18; virginie.philippe@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two arms: AMT and MACT

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2032
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CH (2)