What is JointRep® and what is it used for?
JointRep® injectable implant is a gel composed of materials that are considered safe when in contact with human tissues. The pre-filled syringes that contain these components have to be mixed together to create the final gel that can be used in an arthroscopic procedure. An arthroscopy is a minimally invasive procedure where the surgeon makes a small incision on the joint to insert narrow tubes. This allows the surgeon to view inside your joint with a camera and repair any damage in your joint (bone or cartilage, which covers the tip of the bone). JointRep® is injected through these narrow tubes to cover any defect in the cartilage and assist in the healing of the joint. Once JointRep® covers the hole in the cartilage, it will dense up from being in contact with body temperature.
Intended Use/Indications
JointRep® injectable implant is indicated for implantation for the treatment of isolated cartilage defects grade III and IV (ICRS/Outerbridge scores) of the knee joint in combination with microfracture surgery. Use is not appropriate in the presence of more generalized degeneration, meniscal deficiency or established osteoarthritis.
The ICRS Score can be found below.
How does JointRep® work
JointRep® injectable implant is applied to fill out cartilage lesions. JointRep® hydrogel implant conforms to lesion volume and sticks to cartilage lesion contours.
JointRep® implant enables cartilage repair tissue ingrowth and formation of cartilage repair tissue. Ultimately, the JointRep® implant degrades locally and is totally degraded/dissolved within 6 months post-operation.
Use of JointRep®
Avoid the use of JointRep® implant
ï‚·• if you have severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
• if have known hypersensitivity to shellfish (crustaceans; shrimps) or to any of the components of shellfish.
• if you are contraindicated for arthroscopic technique or when microfracture is contraindicated.
The JointRep® injectable implant is a non-metallic organic implant and has no or negligible magnetic field interactions, and therefore is considered safe for patients in an MRI environment.
The safety and effectiveness for use of JointRep® injectable implant has not been established in children or adolescents under the age of 18.
Pregnancy and breast-feeding
The safety and effectiveness for use of JointRep® injectable implant has not been established for pediatric use or use in pregnant or nursing women.
Using JointRep® with food and drink
There are no indications of any effect of food and drink on the use of JointRep® injectable implant.
Driving and using machines
There are no indications of any effect of the use of JointRep® injectable implant on alertness and concentration.
Post-op Rehabilitation following the administration of JointRep® injectable implant
Following the arthroscopic procedure with JointRep® injectable implant, a post-op recovery/rehabilitation program is required. Your healthcare professional will provide the indications for the post-op recovery/rehabilitation program specific to the treatment with JointRep® injectable implant. It is highly important to follow and comply with the post-op recovery/rehabilitation program.
Using other medicines
Always tell your doctor/surgeon which medicines or herbal products you are already using. Also tell any other doctor or surgeon who prescribes another medicine (or the pharmacist) that you have been treated with JointRep® injectable implant.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may, as with any injection, experience increased bruising or bleeding at the injection site.
Treatment with JointRep® injectable implant should not be combined with oral Glucosamine treatment. Prior to treatment, talk to your healthcare professional if you take oral Glucosamine.
Suggested rehabilitation can be found below in PDF form.
Possible side effects and complications
Side-effects
Side effects are symptoms that occur due to the surgery and are a normal part of the recovery from the operation.
No side-effects specific to JointRep® injectable implant have been reported/noticed.
Side-effects related to arthroscopic procedures can occur since JointRep® injectable implant is arthroscopically administered. For joint arthroscopy, this includes:
ï‚· • A sore joint which may last for several weeks after the operation.
ï‚· • Swelling of the joint which may last for several days.
Complications
Most patients do not experience complications from arthroscopic procedures. For any joint arthroscopic procedures, however, there are some risks. These are usually minor and treatable.
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Arthroscopy-related complications include:
• Accidental damage to structures inside or near to the joint
• Infection
• Excessive bleeding
• Blood clots and damage to blood vessels or nerves
• Numbness
• Allergy to local anaesthetics, or complications of anaesthesia if a general anaesthetic is used
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After the arthroscopy, see your healthcare professional urgently if you:
ï‚·ï‚·ï‚· • Have pain or swelling in the joint, which becomes worse. In particular, if the joint is also hot, tender and red. (This may indicate bleeding or infection in the joint.)
ï‚·ï‚·ï‚·• Have a have a total blockage of the joint.
• Develop a high temperature.
• See fluid, pus or blood coming from the site of the cut (incision).
• Develop numbness or tingling near to the joint (which may indicate nerve damage).
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ï‚·ï‚·Talk to your Healthcare professional, if, after the arthroscopy, you experience repetitive:
ï‚·• headache, tiredness, feeling sick, abdominal pain, indigestion, diarrhoea, constipation, rash, itching, flushing.
Reporting events
In case of serious side-effects, adverse events or incidents encountered with JointRep® injectable implant, please contact your healthcare professional and/or your governing health authorities. Your healthcare professional shall
report to the JointRep® supplier and manufacturer and to the national regulatory authority. You can also contact directly the regulatory authority with the information below:
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If not listed, please make sure to contact your nation regulatory authority for medical devices to learn more about reporting side effects or events related to the use of the medical device.
Further information
The JointRep® implant ingredients are:
ï‚·ï‚·• Water
• Poly-D-Glucosamine hydrochloride and D-Glucosamine hydrochloride
• Sodium Carbonate
One JointRep® injectable implant (maximal volume: 4.2 mL) comprises a maximum of 0.0902 g of Poly-D-Glucosamine hydrochloride and of 0.0743 g of D-Glucosamine hydrochloride. The JointRep® injectable implant is a single-use device and does not require monitoring or maintenance.
Manufacturer
OLIGO MEDIC, INC.
500 Boulevard Cartier Ouest, Laval, Quebec H7V 5B7 Canada
http://www.oligomedic.com - info@oligomedic.com
+1 (450) 680-3371