Joint-preserving technique for chondral tissue regeneration
StaMP
StaMP
GUIDED AUTOLOGOUS CHONDROGENESIS ON THE EXTRACELLULAR SCAFFOLD
The latest minimally invasive single-stage articular cartilage regeneration technique from Russia
The latest minimally invasive single-stage articular cartilage regeneration technique from Russia
Advantages of the "StaMP" technique
The key principle is the induction of natural repair processes
by biologically active components
by biologically active components
- Joint-preserving conceptOur technique allows for avoiding the total
joint replacement1 - Minimally invasive single-stage procedureThe technique implies minimally invasive access and accomplishment of all steps within a single intervention2
- Treatment of large chondral and osteochondral defectsThe size of the lesion is from 1 to 3 cm in diameter and up to 7 mm depth3
- Ease of useDoes not require any special qualification of the user4
- The unique matrix is involvedThe scaffold for chondrogenesis is a complete equivalent of the extracellular matrix, i.e. the basis of cartilage tissue5
- Affordability6
"StaMP" is a unique combination of the advantages of the known surgical approaches
and the latest achievements in regenerative medicine
and the latest achievements in regenerative medicine
Approach
Mechanism
Effect
Microfracturing (needling)
Subchondral needling procedure
Induction of the reparative chondrogenesis through autologous mesenchymal stem cells' (MST) migration
Autologous chondroplasty
Autologous transplantation of the fragmented cartilage tissue from the unloaded areas
3D filling of the cartilage defect
CHONDRO-SCAFFOLD
The treated surface is covered by the membrane "Chondro-SCAFFOLD"
- mechanical stabilization of the "super clot"
- active interaction with the "super clot" components, and binding of progenitor cells
- transformation into a healthy hyaline-like tissue within 5-7 weeks
- induction of chondrogenesis and reparative processes through the release of biologically active components
PRP-Therapy
Injection of autologous platelet-rich plasma
- super clot enrichment
- activation of regenerative processes by growth factors
- Microfracturing (needling)Mechanism
Subchondral needling procedure
Effect
Induction of the reparative chondrogenesis through autologous mesenchymal stem cells' (MST) migration1 - Autologous chondroplastyMechanism
Autologous transplantation of the fragmented cartilage tissue
from the unloaded areas
Effect
3D filling of the cartilage defect2 - Chondro-SCAFFOLDMechanism
The treated surface is covered by the membrane "Chondro-SCAFFOLD"
Effect- mechanical stabilization of the "super clot"
-
active interaction with the "super clot" components, and binding
of progenitor cells - transformation into a healthy hyaline-like tissue within 5-7 weeks
-
induction of chondrogenesis and reparative processes through the
release of biologically active components
3 - PRP-плазмотерапияMechanism
Injection of autologous platelet-rich plasma
Effect- super clot enrichment
- activation of regenerative processes by growth factors
4
Indications for the technique
- Focal chondral and osteochondral defects
(grade III-IV according to Outerbridge) - Size of the lesion from 1 to 3 cm in diameter
and up to 7mm depth - Healthy cartilage adjacent to the defect
- Patient age from 18 to 50 y.o.
The choice of the cartilage regeneration technique always depends on various factors (joint condition, presence of concomitant diseases, patient age and others). Intervention shall only be indicated after a comprehensive medical examination.
Contraindications
- Chondral surface defect of more than 3 cm in diameter
and more than 7 mm depth - Unstable knee joint, meniscectomy,
varus/valgus knee deformity - Presence of the diagnosed allergy to collagen
of xenogenic origin - Somatic immune disorders
- Osteoarthritis stage 2 or higher
- Joint arthritis
- Hemophilia A/B
With special precautions, it can be applied in the patients of the following categories:
- undergoing long-term therapy with corticosteroids
- with coagulation disorder
- with acute or chronic infection at the surgical site
- with an uncompensated metabolic disorder
- with autoimmune diseases
"STAMP" — GUIDED AUTOLOGOUS CHONDROGENESIS ON EXTRACELLULAR SCAFFOLD
Membrane "Chondro-SCAFFOLD"
Matrix that induces chondrogenesis
MEMBRANE "CHONDRO-SCAFFOLD"
The latest achievement of regenerative medicine
and tissue engineering
and tissue engineering
Design concept
In vivo, cells of living tissues are located in the extracellular matrix, which is a complex of organic and inorganic compounds that fill the space between cells. The extracellular matrix consists of three main components: structural collagen, proteoglycans, and glycoproteins. The latter, in turn, act as receptors in the "production" of the intercellular matrix, ensure cell attachment and growth, and induce cell differentiation and migration. The concept for the development "Chondro-SCAFFOLD" laid on this essential principle.
Structure
The product is a three-dimensional volumetric implantable biomaterial - a complete equivalent of the extracellular matrix - which serves as a base material for cartilage tissue. The product has a natural tissue organization, replicates the composition and architectonics of structural molecules, and has natural biologically active inductors.
Composition
The raw material for Chondro-SCAFFOLD is a highly purified extracellular xenogenic matrix - pSIS (porcine small intestine submucosa). The patented multistage technology of chemical and biological treatment of raw materials allows the complete removal of cellular elements, and simultaneously preserve the natural architecture of fibrillar proteins and the presence of biological molecules. The latter endows the biomaterial with natural background induction features for tissue repair. Among proteins, there are glycoproteins (fibronectin and laminin) that promote adhesion, proliferation, and migration of cells; glucosaminoglycans (hyaluronic acid and chondroitin sulfate A) that reduce inflammation, provide cell binding and attachment; proteoglycans (decorin and heparan-sulfate) that prevent scar tissue formation, participate in fibrillary regulation of collagen, stimulate angiogenesis.
Mechanism of conduct
Scaffolds based on the extracellular matrix are successfully used in regenerative medicine for the cultivation of stem cells - fibroblasts and mesenchymal stromal cells of bone marrow. Additionally, pSIS-scaffold is an ideal matrix that favors autologous chondrogenesis. The Chondro-SCAFFOLD membrane is incorporated by the recipient's cells within a short period of time and is completely transformed (5 to 7 weeks) into a healthy hyaline-like tissue without scarring or adhesions.
Physical properties
The membrane has excellent tensile strength characteristics. Testing carried out on the INSTRON-5944 BIO PULS machine demonstrated comparable results on the elastic deformation parameters of the pSIS-based matrix and xenopericardium, which is widely used in repair surgery. The product is resistant to cutting through by a surgical thread, whereas the structure of the fibers provides high resistance to stretching and tearing. Chondro-SCAFFOLD membrane can be fixed with a suture surgical material or surgical glue.
Advantages of Chondro-SCAFFOLD
The membrane helps to reduce pain syndrome in the postoperative period and favors a more rapid and effective regeneration of chondral tissue. Its safety and efficacy has been proved.
It is a highly purified natural extracellular matrix
Actively interacts with the super clot components
Quickly transforms into a healthy hyaline-like tissue
Reliably stabilizes and protects the super clot
Induces cell growth, attachment, and differentiation
Contains active biological inductors
Inhibits the development of chondral diseases
Has high mechanical and tensile strength properties
Quality and safety
The Chondro-SCAFFOLD membrane is made of raw material derived from animals. The basis of the product is a matrix consisting of collagen, which is known to be a very weak antigen. A multi-stage treatment of the raw material results in a deep cleaning and complete decellularization of the matrix. Hence, the end product is free from immunogenic potential. The rigorous control of production processes with a comprehensive traceability system mitigates any possibility to transmit diseases from animals. Chondro-SCAFFOLD membrane is manufactured by the Russian company "Cardioplant" (Russia's leading manufacturer of implantable products based on biological materials) within the standardized production procedures in clean rooms (ISO 8 – ISO 5 classes of cleanliness) and under strict quality control. The manufacturing conditions of the class III product comply with the requirements of the international standard ISO 22442 "Medical products using tissues and their derivatives of animal origin" and guarantee high quality, effective and safe implantable end product.
«STAMP» — GUIDED AUTOLOGOUS CHONDROGENESIS ON EXTRACELLULAR SCAFFOLD
Surgical technique
Main stages of the operation
1
ARTHROSCOPY/ARTHROTOMY
The size and degree of the chondral tissue lesion are analyzed, taking into account the indications and contraindications to the application of the technique. Arthrotomy is performed in the plane of the lesion when the indications are present.
Photo ➜
2
PREPARATION OF THE BEDDING
AND MICROFRACTURING
AND MICROFRACTURING
Loose cartilage flaps and debris are removed so that a viable bottom and smooth edges of the defect are exposed. The bone is pierced to a depth of 4–6 mm until the hemorrhages appear on the surface, 3–4 per 1 cm2. It is necessary to make sure that there is sufficient bleeding from the subchondral layer.
Photo ➜
3
PREPARATION AND FIXATION OF THE
CHONDRO-SCAFFOLD MEMBRANE
CHONDRO-SCAFFOLD MEMBRANE
The membrane is exposed to a 0.9 % sodium chloride solution for at least 5 minutes. After hydration, the membrane is measured against the defect and then precisely cut to shape by scissors. It is necessary to fully cover the damaged area without overlapping the intact hyaline cartilage.
The shaped membrane is fixed by the nodal suture pattern along the perimeter with an absorbable surgical suture 4\0. The distance between the stitches shall be 1–2 mm. The last stitch is not applied to give access to the implantation of the crushed cartilage.
The shaped membrane is fixed by the nodal suture pattern along the perimeter with an absorbable surgical suture 4\0. The distance between the stitches shall be 1–2 mm. The last stitch is not applied to give access to the implantation of the crushed cartilage.
Photo ➜
4
AUTOLOGOUS CHONDROPLASTY
Hyaline cartilage is sourced from the low-loaded joint surface or from the detached osteochondral block. After crushing by a scalpel knife to the size of up to 1 mm3, a surgeon evenly distributes the cartilage under the membrane placing 3–4 fragments per 1 cm of the defect. Then the last stitch is applied to the membrane, thus maximizing the sealing of the defect and stabilizing the super clot.
Photo ➜
5
PRP-THERAPY
Blood is drawn from the patient's vein to obtain platelet-rich plasma. Plasma is prepared according to the standard procedure, depending on the manufacturer, and introduced under the membrane until it swells up.
The surgical technique "StaMP" with Chondro-SCAFFOLD membrane can be carried out without PRP-therapy, however, the clinical results are significantly better with the injection of platelet-rich plasma under the membrane to the state of tension underneath.
The surgical technique "StaMP" with Chondro-SCAFFOLD membrane can be carried out without PRP-therapy, however, the clinical results are significantly better with the injection of platelet-rich plasma under the membrane to the state of tension underneath.
Photo ➜
6
FINAL STAGE OF THE OPERATION
To prevent delamination, the membrane should not overlap the edge of adjacent healthy cartilage. Before the operation is completed, it is necessary to ensure a stable position of the matrix by flexion and extension of the joint. The operation ends with thorough wound closure. Immobilization of the joint for 3–5 days is recommended.
Photo ➜
ARTHROSCOPY / ARTHROTOMY
The size and degree of the chondral tissue lesion are analyzed, taking into account the indications and contraindications to the application of the technique. Arthrotomy is performed in the plane of the lesion when the indications are present.
Photo ➜
PREPARATION OF THE BEDDING AND MICROFRACTURING
Loose cartilage flaps and debris are removed so that a viable bottom and smooth edges of the defect are exposed. The bone is pierced to a depth of 4–6 mm until the hemorrhages appear on the surface, 3–4 per 1 cm2. It is necessary to make sure that there is sufficient bleeding from the subchondral layer.
Photo ➜
PREPARATION AND FIXATION OF THE
CHONDRO-SCAFFOLD MEMBRANE
CHONDRO-SCAFFOLD MEMBRANE
The membrane is exposed to a 0.9 % sodium chloride solution for at least 5 minutes. After hydration, the membrane is measured against the defect and then precisely cut to shape by scissors. It is necessary to fully cover the damaged area without overlapping the intact hyaline cartilage.
The shaped membrane is fixed by the nodal suture pattern along the perimeter with an absorbable surgical suture 4\0. The distance between the stitches shall be 1–2 mm. The last stitch is not applied to give access to the implantation of the crushed cartilage.
The shaped membrane is fixed by the nodal suture pattern along the perimeter with an absorbable surgical suture 4\0. The distance between the stitches shall be 1–2 mm. The last stitch is not applied to give access to the implantation of the crushed cartilage.
Photo ➜
AUTOLOGOUS CHONDROPLASTY
Hyaline cartilage is sourced from the low-loaded joint surface or from the detached osteochondral block. After crushing by a scalpel knife to the size of up to 1 mm3, a surgeon evenly distributes the cartilage under the membrane placing 3–4 fragments per 1 cm of the defect. Then the last stitch is applied to the membrane, thus maximizing the sealing of the defect and stabilizing the super clot.
Photo ➜
PRP-THERAPY
Blood is drawn from the patient's vein to obtain platelet-rich plasma. Plasma is prepared according to the standard procedure, depending on the manufacturer, and introduced under the membrane until it swells up.
The surgical technique "StaMP" with Chondro-SCAFFOLD membrane can be carried out without PRP-therapy, however, the clinical results are significantly better with the injection of platelet-rich plasma under the membrane to the state of tension underneath.
The surgical technique "StaMP" with Chondro-SCAFFOLD membrane can be carried out without PRP-therapy, however, the clinical results are significantly better with the injection of platelet-rich plasma under the membrane to the state of tension underneath.
Photo ➜
FINAL STAGE OF THE OPERATION
To prevent delamination, the membrane should not overlap the edge of adjacent healthy cartilage. Before the operation is completed, it is necessary to ensure a stable position of the matrix by flexion and extension of the joint. The operation ends with thorough wound closure. Immobilization of the joint for 3–5 days is recommended.
Photo ➜
SIDE EFFECTS
In rare cases, allergic reactions to collagen and minor reactions resulting in local inflammation are possible. Possible complications of the surgical procedure include hemarthrosis/synovitis, soreness of the surgical site, wound infection, necrosis, and flap rejection (loss or deterioration of membrane function).
In rare cases, allergic reactions to collagen and minor reactions resulting in local inflammation are possible. Possible complications of the surgical procedure include hemarthrosis/synovitis, soreness of the surgical site, wound infection, necrosis, and flap rejection (loss or deterioration of membrane function).
Arthroscopy/Arthrotomy
The size and degree of the chondral tissue lesion are analyzed, taking into account the indications and contraindications to the application of the technique. Arthrotomy is performed in the plane of the lesion when the indications are present.
Preparation of the bedding and microfracturing
Loose cartilage flaps and debris are removed so that a viable bottom and smooth edges of the defect are exposed. The bone is pierced to a depth of 4–6 mm until the hemorrhages appear on the surface, 3–4 per 1 cm2. It is necessary to make sure that there is sufficient bleeding from the subchondral layer.
Preparation and fixation of the chondro-scaffold membrane
The membrane is exposed to a 0.9 % sodium chloride solution for at least 5 minutes. After hydration, the membrane is measured against the defect and then precisely cut to shape by scissors. It is necessary to fully cover the damaged area without overlapping the intact hyaline cartilage.
The shaped membrane is fixed by the nodal suture pattern along the perimeter with an absorbable surgical suture 4\0. The distance between the stitches shall be 1-2 mm. The last stitch is not applied to give access to the implantation of the crushed cartilage.
The shaped membrane is fixed by the nodal suture pattern along the perimeter with an absorbable surgical suture 4\0. The distance between the stitches shall be 1-2 mm. The last stitch is not applied to give access to the implantation of the crushed cartilage.
Autologous chondroplasty
Hyaline cartilage is sourced from the low-loaded joint surface or from the detached osteochondral block. After crushing by a scalpel knife to the size of up to 1 mm3, a surgeon evenly distributes the cartilage under the membrane placing 3-4 fragments per 1 cm of the defect. Then the last stitch is applied to the membrane, thus maximizing the sealing of the defect and stabilizing the super clot.
PRP-therapy
Blood is drawn from the patient's vein to obtain platelet-rich plasma. Plasma is prepared according to the standard procedure, depending on the manufacturer, and introduced under the membrane until it swells up.
The surgical technique "StaMP" with Chondro-SCAFFOLD membrane can be carried out without PRP-therapy, however, the clinical results are significantly better with the injection of platelet-rich plasma under the membrane to the state of tension underneath.
The surgical technique "StaMP" with Chondro-SCAFFOLD membrane can be carried out without PRP-therapy, however, the clinical results are significantly better with the injection of platelet-rich plasma under the membrane to the state of tension underneath.
Final stage of the operation
To prevent delamination, the membrane should not overlap the edge of adjacent healthy cartilage. Before the operation is completed, it is necessary to ensure a stable position of the matrix by flexion and extension of the joint. The operation ends with thorough wound closure. Immobilization of the joint for 3-5 days is recommended.
"STAMP" — GUIDED AUTOLOGOUS CHONDROGENESIS ON EXTRACELLULAR SCAFFOLD
Postoperative period
Recommendations for postoperative management of the patients
The early development of joint movements plays a key role in the postoperative period.
The use of physiotherapy is advisable. Intra-articular drainage is not used. In order to evacuate the postoperative hematoma, a puncture of the joint can be performed.
The use of physiotherapy is advisable. Intra-articular drainage is not used. In order to evacuate the postoperative hematoma, a puncture of the joint can be performed.
Osteochondral defects of the knee and hip joints
WEEK 1-2
WEEK 3-6
AFTER THE 6TH WEEK
RELIEVE OF LOAD
Absence of the load to the leg.
Walking with crutches.
Walking with crutches.
Light load to the foot.
Walking with crutches.
Walking with crutches.
A gradual increase to full load over 2 weeks. Intense muscle and coordination training.
MOTION
Immobilization for the first 48-72 hours. Then see the table below.
The development of movements in the joint.
Any movements except those associated with pain.
PHYSICAL ACTIVITY
Refrain from physical activity.
Water gymnastics.
Swimming.
Walking.
Swimming.
Walking.
Water run.
After 8 weeks: bike.
After 6 months: jogging, skating.
After 6-12 months: skiing.
After 12-18 months: contact sports.
After 8 weeks: bike.
After 6 months: jogging, skating.
After 6-12 months: skiing.
After 12-18 months: contact sports.
Relieve of load
Absence of the load to the leg.
Walking with crutches.
Motion
Immobilization for the first 48-72 hours. Then see the table below.
Physical activity
Refrain from physical activity.
Absence of the load to the leg.
Walking with crutches.
Motion
Immobilization for the first 48-72 hours. Then see the table below.
Physical activity
Refrain from physical activity.
Relieve of load
Refrain from physical activity.
Motion
Refrain from physical activity.
Physical activity
Water gymnastics.
Swimming.
Walking.
Refrain from physical activity.
Motion
Refrain from physical activity.
Physical activity
Water gymnastics.
Swimming.
Walking.
Relieve of load
A gradual increase to full load over 2 weeks. Intense muscle and coordination training.
Motion
A gradual increase to full load over 2 weeks. Intense muscle and coordination training.
Physical activity
Water run.
After 8 weeks: bike.
After 6 months: jogging, skating.
After 6-12 months: skiing.
After 12-18 months: contact sports.
A gradual increase to full load over 2 weeks. Intense muscle and coordination training.
Motion
A gradual increase to full load over 2 weeks. Intense muscle and coordination training.
Physical activity
Water run.
After 8 weeks: bike.
After 6 months: jogging, skating.
After 6-12 months: skiing.
After 12-18 months: contact sports.
Rehabilitation exercises to restore joint mobility
- Lie on your back, straighten your leg, then tighten your quadriceps
for 3-5 secondsrepeat 7 times every 4 hours✔ - Lie on your back, and perform isometric contractions
of the thigh musclesrepeat 7 times every 4 hours✔ - Lie on your back, straighten your leg, slowly lift it up and return to the initial positionrepeat 10 times every 4 hours✔
- Lie on your back, slowly straighten the operated leg and lift it up, abduct and return to the initial positionrepeat 10 times every 2 hours✔
- Lie on the healthy side, straighten the operated leg, abduct it and hold for
10 seconds, then return to the
initial positionrepeat 10 times every 2 hours✔
Together we will make the cartilage healing
accessible and effective
accessible and effective
The technology was developed in a close collaboration of bioengineers and leading medical specialists in Russia. The engineering team is always open to a discussion. In case of questions regarding the surgical technique, membrane properties, postoperative management of patients and other issues, please, contact us by filling out the inquiry form. We are interested in the distribution of the latest novel methods in clinical practice.
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