What is ChondroFiller®?
ChondroFiller is a product line for treatment of defects in the hyaline joint cartilage. It is a biological, acellular cartilage implant on a collagen basis for autoregenerative treatment of joint cartilage defects. The first generation of ChondroFiller – the ChondroFillerGel – was licensed in 2012. This is a pressure-resistant gel plug on a collagen basis. In 2013 the next generation was then already launched with the patented ChondroFiller® liquid. On this product the collagen is liquid and is delivered arthroscopically with a two-chamber syringe into the affected joint. The liquid collagen then forms a gel directly in the cartilage defect and thus adapts perfectly to its shape.
What is the difference between ChondroFiller® liquid and ChondroFillerGel?
ChondroFillerGel was the first collagen implant in the ChondroFiller® product range. It was a gel plug that was available in various sizes (height, diameter). This implant needed to be trimmed to size to match the individual requirements, which represented an additional step for the orthopaedic surgeon. ChondroFiller® liquid is the patented and worldwide unique successor product to this implant. The liquid components of the product are supplied in a two-chamber syringe. By placing a mixing adapter on the syringe and pressing out the components, they are mixed and the pH-dependent gelation of the collagen starts immediately once the collagen has been implanted in the cartilage defect.
What is the classification of ChondroFiller® liquid?
For which types of damage to joint cartilage can ChondroFiller® liquid be used?
A prerequisite for treatment is grade III or grade IV joint cartilage damage based on the Outerbridge classification, as well as deep and/or subchondral defects and osteochondral defects in the case of partial injuries to the joint cartilage.
ChondroFiller® is available in different volumes for treatment of defects of different sizes:
- up to 3 cm2: ChondroFiller® liquid, HCFL-23
- up to 2 cm2: ChondroFiller® liquid, HCFL-15
- up to 1.5 cm2: ChondroFiller® liquid, HCFL-10
The use of ChondroFiller® liquid in other parts of the body, for example in the outer ear or in breast tissue, is not permitted.
For which indications is ChondroFiller® liquid used?
- Preserved cartilage shoulder
- Intact surrounding cartilage
- Intact corresponding
- Articular surface (damage to the corresponding articular surface up to a maximum Outerbridge classification of grade II is permitted)
- Intact meniscus (a partial resection of up to a maximum of 1/3 of the total volume is permitted)
- Intact ligament guidance, physiological leg axis
- Free joint mobility
- Patient’s age: 18 or older
- Outerbridge defect classification: grade III and IV
- Defect size < 3 cm2
Are there any contraindications for ChondroFiller® liquid?
- Hypersensitivity and/or allergy to collagen or rat protein
- Multi-compartmental arthrosis
- Hematopoietic diseases
- Malignant disorders
- Neurological diseases
- Increased risk of bleeding
- Pregnant and breastfeeding women
- Incapacitated and compulsory treatment patients
- Patients with a cartilage defect ≥ 2.5 cm in diameter
- Joint stiffness
- Joint infections
- Metabolic disorders
- Leg malalignment > 5°
- If surgical procedures are necessary in connection e.g. with
- Ligament injuries,
- Meniscus injuries,
- Leg malalignment of > 5°,
- Patellar malalignment or
- Other orthopaedic/accident surgery injuries in which cartilage defects are discovered in the surrounding tissue during the procedure that meet the above criteria; ChondroFiller® liquid can also be used in these cases in accordance with the application rules set out above.
How many surgical procedures are required for ChondroFiller® liquid?
Do cells need to be cultivated for the ChondroFiller® technique?
How does the matrix conversion from collagen type 1 to collagen type 2 take place?
How do the cells get into the ChondroFiller® liquid?
Which cells migrate into the ChondroFiller® liquid?
Can it be demonstrated what quality of cartilage is produced by ChondroFiller® liquid?
How was a qualitative analysis of the regenerated cartilage performed?
Does ChondroFiller® liquid contain cytokines or growth factors?
What does ChondroFiller® liquid consist of?
Is there a risk that patients could infect themselves via the ChondroFiller® collagen implant with hantavirus or other pathogens that are transmitted from rats to humans?
What advantage does collagen from rat tail tendons have over collagen produced from tissue from pigs, horses or cattle?
Are any side effects known?
What is the mechanism by which gelation of the liquid component into a pressure-resistant gel takes place?
How can I obtain ChondroFiller® liquid?
ChondroFiller® liquid is sold worldwide in more than 20 countries and can be obtained via our sales partners or from the manufacturer.
Which joints has ChondroFiller® liquid been used on so far?
ChondroFiller® liquid has been used in the following joints to date: knee, hip, upper ankle joint, shoulder, metatarsophalangeal joint, thumb basal joint, wrist.
How is ChondroFiller® liquid stored?
How long can ChondroFiller® liquid be kept for?
Can ChondroFiller® liquid be kept in the refrigerator?
Can ChondroFiller® liquid be refrozen after thawing?
How quickly does ChondroFiller® liquid thaw?
Which accessories are required for treatment with ChondroFiller® liquid?
In which sizes is ChondroFiller® liquid available?
How long does the ChondroFiller® liquid remain in the body? Does the procedure need to be repeated in similar fashion to the technique with hyaluronic acid?
Does microfracture surgery (MFx) need to be performed prior to treatment with ChondroFiller® liquid?
How is the high-quality collagen type 1 implanted in the joint in the ChondroFiller® liquid technique?
How does the patient need to be positioned?
Does the defect zone need to be dried prior to implantation, and how is this drying performed?
How is wound cleaning (debridement) performed?
How is ChondroFiller® liquid prepared for implantation?
How is the defect zone filled?
How quickly does ChondroFiller® liquid form a solid collagen gel?
How can the height of the implant be matched to the surrounding cartilage?
Further treatment of the patient after filling of the defect?
What rehabilitation measures should take place after treatment with ChondroFiller® liquid?
The follow-up treatment is mainly determined by the anatomic location of the defect in the joint. There are two fundamental options:
defects located in the main load area of the joint, which are therefore subjected to an axial load, and
- defects on the knee joint located on the patella or on its corresponding articular surfaces, i.e. on the femoral trochlea, which are loaded only during flexion of the joint.
In both cases, the follow-up treatment is based on the relevant recommendations of the professional societies for trauma surgery DGU and orthopaedics DGOOC (Pietschmann 2012):
Main loading zone of the femoral condyles/talus:
- Mobilisation on day 2 post-surgery
- 20 kg partial weight bearing on the operated limb for 6 weeks
- Exercise bar (CPM) 2x daily for 1 hour
- From week 7: increase load by 30 kg every 2 weeks to full weight bearing
- After reaching full weight bearing capability: cycling and swimming permitted, careful build-up of muscle through isometric training
- Jumping, running and contact sports permitted after 1 year
Patellar and retropatellar bearings:
- Mobilisation on day 2 post-surgery
- Flexion of the knee joint is limited with an IROM rail for 3 weeks to 0-30°.
- 20 kg partial weight bearing on the operated limb for 1 week
- Full weight bearing permitted from week 2
- From week 3: increase in flexion by 30° every 2 weeks, when flexion reaches 90° the IROM rail can be removed.
- Once 90° flexion is attained: cycling and swimming permitted, careful build-up of muscle through isometric training
- Sports with a high risk of falls are not permitted until after 1 year.
Detailed information about rehabilitation measures can be found in the PDF file Follow-up treatment/Rehabilitation