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| Name | Class |
|---|---|
| Virginie PHILIPPE | UNKNOWN |
| Lee Ann LAURENT APPLEGATE | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MACT | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
For final inclusion, an additional exclusion criteria will be assessed after randomization:
- Positive to HIV, HBV, HCV, syphilis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin MARTIN, MD | Contact | 021 314 76 79 | 41 | robin.martin@chuv.ch |
| Virginie PHILIPPE, Ph-D | Contact | 021 314 90 18 | 41 | virginie.philippe@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Robin MARTIN, MD | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fribourgeois- HFR | Fribourg | Canton of Fribourg | 1708 | Switzerland |
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| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002357 | Cartilage Diseases |
| D003240 | Connective Tissue Diseases |
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Two arms: AMT and MACT
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| 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. |
|
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| Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the femorotibial joint. |
| 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. |
| 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. |
| Centre Hospitalier Universitaire Vaudois - CHUV | Lausanne | Canton of Vaud | 1011 | Switzerland |
|
| D017437 |
| Skin and Connective Tissue Diseases |