NCT05651997

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-12-01
• Primary completion: 2028-06-01
• Completion: 2032-06-01
• First posted: 2022-12-15
• Last updated: 2026-03-12

Locations

2 sites across 1 country: Switzerland