TMJ Parametro Classico Total Temporomandibular Joint Prosthesis
2 Personalized total TMJ replacement system (Parametro Classic & Parametro Saddle ) Patient Information in English This patient information is to help explain issues regarding TMJ replacement surgery. Always rely on your doctor for information about your specific problem, for treatment recommendations and instructions. What is the Temporomandibular Joint (TMJ)? The TMJ is the jaw joint, which allows you to open and close the mouth. It is dissimilar to a hip joint as the ball portion also slides forward and sideward, besides showing rotation. The ball portion is the mandibular (lower jaw) condyle and the socket portion is the glenoid fossa. There is a disc between the glenoid fossa (further fossa ) and the mandibular condyle (further condyle ), which allows the condyle to slide smoothly while chewing, speaking and breathing. Muscles and ligaments keep the joint together and provide the force required to move the mandible. What are Temporomandibular Disorders (TMD)? TMD is the joint that is diseased. Various factors can cause TMD which results in restricted jaw movement and facial pain. Some symptoms include pain in the TMJ (arthromyalgia), headaches, earaches, popping of the joint, difficulty of opening or closing of the mouth (closed or open lock), dizziness, sensation of fullness in the ear and reduced hearing. What is the personalized Total TMJ Replacement System Parametro? The Parametro system is a prosthetic joint similar to a knee or hip prosthesis. The following parts, which make up the system, are made of materials with over years of successful use in orthopedic joint replacement. 1. Mandibular component The mandibular component is made of titanium (Ti-6AL-4V) alloy. It contains no nickel, and is fully conditioned for bone and soft tissues (alumina blasted, acid etched, plasma surface activated) 2. Fossa component The fossa component is made of a long-chained polyethylene, showing excellent wear resistance during mechanical testing. 3. Screws Both the condyle and fossa components are attached to bone using titanium alloy screws. How is the majority of TMD patients treated? Most TMD patients do not require surgery. They can be treated conservatively with one or a combination of the following: - soft diet - analgesics & anti-inflammatory drugs - physical therapy & hot /cold pack applications - mouth splints (bite plates) - muscle relaxants
3 - dental treatment including bite adjustments and orthodontics Only those patients who have an end-stage problem inside the joint itself that does not respond to conservative care or tissue-sparing surgery may be candidates for joint replacement surgery. What types of surgery are performed in the TMJ? There are a few options: - arthrocentesis - arthroscopy - arthroplasty (open joint surgery) - total joint replacement Arthroscopy is a procedure in which an endoscope is placed inside the joint for diagnostic purposes and to treat inflammation and discs that are "stuck" or displaced. When the disc is badly displaced, an open arthroplasty can be performed to repair, reposition or replace the disc. Only when there is severe endstage degeneration of the disc and condyle, a fibrous or boney ankylosis, a total joint replacement can be considered. Who is a candidate for the Total TMJ Replacement System Parametro? Candidates are patients who have finished growing and have TMJ problems along with one of the following indications: Arthritic conditions: e.g. osteoarthritis, rheumatoid arthritis, traumatic arthritis, ankylosis (an abnormal fusion of the joint), revision procedures where other treatments have failed, avascular necrosis (death of tissue due to poor blood supply), multiple operated joints, malunited fractures, congenital malformations, benign and malign tumors. What are the contra-indications for the Total TMJ Replacement System Parametro? - patients with an active infection - patients who do not have enough bone and/or deformed bone or good quality bone to support the device - patients requiring partial TMJ joint reconstruction only - known allergic reaction to any of the materials used in the implants - patients with mental or neurologic conditions who are unwilling or unable to follow postoperative instructions - patients that are still growing - patients with severe parafunctional habits (e.g. clenching, grinding, etc.) - patients with an active foreign body reaction What are the possible complications? - facial swelling and/or pain - facial nerve problems
4 - heterotopic bone formation (bone found in an abnormal place after ankyloses surgery mainly) - implant changes caused by loading and/or wear - implant materials producing particles or corrosion - degenerative changes within the joint surfaces from disease or previous implants - foreign body or allergic reaction to implant components - loosening or displacement with or without removal of the infected implant - wearing-through of the fossa material - neurinoma formation (abnormal growth of nerve tissue) - ear problems - dislocation Placement of an implant in one joint only may result in harmful effects to the joint on the opposite side. Placement of an implant may produce an improper relationship between teeth surfaces that should contact during biting. The Total TMJ Replacement System Parametro has not been studied nor in children nor in pregnant women. Therefor the safety effectiveness for these patients is not known. The safety and effectiveness of revision surgery using a second Parametro is not known. What should I expect after surgery? "Reasonable expectations" after TMJ implant surgery as stated include: - an increased mouth opening - pain reduction - improved chewing ability Outcomes are dependent upon the actual severity of the disease, the number and type of previous treatments and surgeries, the condition of the patient and his/her compliance with postoperative instructions. What precautions should I take after TMJ prosthesis implantation surgery? 1. Follow your surgeon's postoperative instructions, especially those related to physiotherapy, and medication. See your surgeon for scheduled follow-up visits including annual visits after the implantation. 2. Avoid the following: - hard, crunchy, or tacky food - contact sports and big-ball sports - other activities that may put stress on your implants 3. If you have to have other surgeries, not related to your TMJ surgery, please tell your surgeon about the TMJ surgery. Your surgeon will need to know this to prescribe an antibiotic to prevent prosthesis infection.
5 What rehabilitation do I need after surgery? Rehabilitation regimens can vary among physicians and generally include a home-based regimen using your fingers, wooden tongue spatula and with a plastic, hand-held device within 2 days to 2 weeks after the implantation. You may require more or less rehabilitation. Call your doctor if you experience any of the following: - excessive swelling and/or bruising - a blood collection under the skin - sudden pain - suddenly less opening of your mouth and/or locking - an impact to your head such as from an automobile accident Training All surgeons are required to have prior training with the use of this device both by hands-on and educational course instruction. Patient and manufacturer responsibilities I. Request that your implants be returned to CADskills bvba, if all or part are removed for any reason. 2. Notify us and your surgeon if you change your emailing address so that you can be contacted if necessary with information regarding your implants. The TMJ Replacement Register requires to have your current email address on file to be able to contact you at any time after your surgery.