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

NCT ID: NCT05651997

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2032-06-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MACT

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

AMT

Intervention Type: 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.

Interventions

MACT

• 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.

Intervention Type: PROCEDURE

AMT

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.

Intervention Type: PROCEDURE

Other Intervention Names

Third generation of ACI; AMIC

Eligibility Criteria

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 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lee Ann LAURENT APPLEGATE

UNKNOWN

Sponsor Role: collaborator

Virginie PHILIPPE

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Dr. Robin Martin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin MARTIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, Switzerland

Hôpital Fribourgeois- HFR

Fribourg, , Switzerland

Countries

Switzerland

Central Contacts

Robin MARTIN, MD

Role: CONTACT

robin.martin@chuv.ch

021 314 76 79 ext. 41

Virginie PHILIPPE, Ph-D

Role: CONTACT

virginie.philippe@chuv.ch

021 314 90 18 ext. 41

Facility Contacts

Robin MARTIN, MD

Role: primary

robin.martin@chuv.ch

021 314 76 79 ext. 41

Daniel PETEK, MD

Role: primary

daniel.petek@h-fr.ch

78 709 86 04 ext. 41

Other Identifiers

AMT_MACT_OTR

Identifier Type: -

Identifier Source: org_study_id