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

Articular Cartilage Defect Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05651997
• Other study ID #: AMT_MACT_OTR
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2032

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Robin MARTIN, MD
• Phone: 021 314 76 79
• Email: robin.martin[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2032
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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)

For final inclusion, an additional exclusion criteria will be assessed after randomization:

• Positive to HIV, HBV, HCV, syphilis.

Related Conditions & MeSH terms

• Articular Cartilage Defect
• Chondral Defect
• Osteochondritis

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Hôpital Fribourgeois- HFR	Fribourg
Switzerland	Centre Hospitalier Universitaire Vaudois - CHUV	Lausanne	Vaud

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Lee Ann LAURENT APPLEGATE, Virginie PHILIPPE

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the patellofemoral and femorotibial joints.
Other	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).	Up to 60 months.
Other	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)	Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation.
Primary	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	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	Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the femorotibial joint.