CONSENT Issue| 1 CONSENT FOR PERFORMING ELBOW ARTHROSCOPY Witnesses present(to be filled out in the event of an oral consent if written consent is not possible) : Witness 1: Name and surname, Personal Identification Number: ………………………………………………………….. Witness 2: Name and surname, Personal Identification Number: ………………………………………………………….. Reason for inability or refusal of written consent: ………………………………………………………………………... ..…………………………………………………………………………………………………………………………………………......................... Statutory representatives (to be filled out if the person to be operated on is a minor or has a mental health disorder): Representative 1: Name and surname, Personal Identification Number: ……………………………………………….. Representative 2: Name and surname, Personal Identification Number: ……………………………………………….. Affected side: Right Left The recommended surgical procedure shall be performed for the purposes of: Synovectomy Release of elbow contracture Resection of the radiocapitellar plica Resection of the head of the radius Removal of a loose fragment Release of the insertion of extensors at the radial epicondyle in the event of an epicondylitis Other.............................................................................................................................................................. Description of the surgery procedure (a more detailed description of the procedure is available in the Patient Information): 1. The surgery procedure is performed under a general anaesthesia. The procedure of carrying out the general anaesthesia and general anaesthesia-related complications are described in more detail in the form for consenting to anaesthesia. You will receive answers to your questions and any uncertainties from the specialist anaesthetist who will perform the procedure on you. SOG.04/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, Tax ID no.:SI29365678 Page | 1 CONSENT Issue| 1 2. During the surgery, an endoscopic optical instrument with a camera is inserted into the elbow joint, which enables the examination of the inside of the joint. 3. The endoscopic camera is used to examine the joint structures of the humerus, the ulna and the radus and the inside surface of the joint capsule. 4. Structures found to be damaged or changed are repaired with a suitable procedure such as smoothing the joint surfaces, removal of the abnormal synovial membrane or removal of a part of a damaged tissue in a way that will enable the renewal or improvement of the joint’s function. 5. If there are any degenerative bone growths in the joint, they can be removed with grinding. Expected benefits of the recommended surgery: 1. Elimination or decrease of pain in the elbow 2. Increased range of active elbow mobility 3. Decrease or elimination of elbow swelling You will find out the extent you can expect the above benefits related to the surgery depending on the pre-surgery condition of the elbow joint and possible related diseases from the doctor that will perform the procedure. Notes of the doctor with the duty to provide explanation: ………………………………………………………………………………………………………………………………………………………….…. .....………………………………………………………………………………………………………………………………………………………… .……...……………………………………………………………………………………………………………………………………………………. Risks related to the recommended surgery: 1. Every surgery procedure can cause unwanted bleeding in the area where the procedure is performed. The probability of the arthroscopic procedure causing heavy bleeding that would require hospital treatment and transfusion is extremely low. 2. During each surgery procedure, there is the possibility of a bacterial infection occurring which can cause the suppuration of the wound or a bacterial infection of the joint. To reduce the risk of perioperative infection in some cases, the patient may receive a preventive antibiotic before the surgery. If infection of the joint or surgery wound occurs, a long-term treatment with antibiotics is required and in some cases one or more surgical procedures involving rinsing the joint and removing the suppurated and infected soft tissue. 3. During a diagnostic arthroscopic examination of the inside of the joint additional unexpected damage in the joint may be determined during the procedure that might require additional surgical procedures to be performed. 4. Repeat occurrence of the issues. Despite the fact that arthroscopic procedures on the elbow are generally very successful, it is not possible to ensure with certainty that it will successfully remove all issues. Despite a professional and quality performance of the surgical procedure, your issues may persist even after the procedure, may reappear or in exceptional circumstances may be worse than before the procedure. 5. Damage to nerves, blood vessels, tendons or muscles in the area of the elbow joint. Such injuries are extremely rare, but can nonetheless occur. In this case, the injuries are only permanent in exceptional circumstances. Such injuries can result in a loss of strength in a certain part of the arm, loss of the sense of touch, loss of the use of the arm or chronic pain in the arm. Any preexisting nerve damage does not improve after such a surgical procedure or may even deteriorate. After the surgery, a feeling of burning pain, paraesthesia or hypersensitivity may develop. 6. Instrument-related complications. Instruments such as the camera, tissue shavers, various sensors and clips can be damaged in the joint and parts of the instruments can break and remain SOG.04/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, Tax ID no.:SI29365678 Page | 2 CONSENT 7. 8. 9. 10. Issue| 1 in the joint. This requires the removal of the broken part of the instrument from the joint. Such particles can also cause damage to the joint, which can be permanent and severe. After the surgical procedure, chronic pain can develop in the joint. Muscle weakness and limited joint mobility. This does not occur directly due to the procedure, but due to unsuitable post-operative rehabilitation. Long-term limited joint mobility and/or muscle weakness can require the post-operative rehabilitation to be extended or, exceptionally, additional surgery. Joint stiffening and a decrease in muscle strength of the joint could also be permanent. The elbow arthroscopy is a surgical procedure that requires the use of technically complex surgery equipment. Despite top quality medical equipment that was manufactured taking into account all the safety standards, equipment failure during the surgery is possible, which in exceptional circumstances in a worst case scenario can prevent the planned performance of the surgical procedure and require the surgery to be terminated. In this case, an additional surgery or a repeat of the surgical procedure might be required at a later date. Risks and complications related to anaesthesia are explained in the Consent to Anaesthesia form. Despite the fact that it is extremely unlikely, complications are nonetheless possible, such as a myocardial infarction, a stroke, the development of blood clots with resulting blood vessel blockage and even death during or after surgery. The risk that such events develop in your case depends on your general health condition, age and other accompanying diseases. Any of these complications could develop with or without prior warning signs. Elevated blood pressure, diabetes, age over 65, past recovery after a myocardial infraction, recovery after conditions with blood clots, recovery after a stroke, smoking and previous heart surgeries are just some of the conditions that increase such risk. Other accompanying diseases that you have can increase the risk of some of the complications listed above. Every person is unique and can possess some of the additional risk factors due to their health condition, way of life or level of physical activity. Risk factors for per-operative or post-operative complications that apply to you are: (the suitable option is encircled by the doctor) 1. diabetes 2. smoking 3. obesity 4. poor general physical condition 5. excessive alcohol consumption 6. age above 65 7. Other: .................................................................................................................................................... Other treatment options: 1. You could acquiesce to the elbow injury and get used to the limited joint function. 2. You can continue physical therapy, which in time may somewhat mitigate your issues with the elbow or improve the joint function. 3. Local interventions with corticostereoid, which when administered with a limited frequency can decrease the pain in the joint. 4. You could take analgesics that will decrease the pain in your joint. Post-surgery plan: The surgical procedure is only a part of the process of treating your elbow injury. After the surgery, a longer period of physical therapy will be required that in some cases must last up to several months after surgery. To ensure the highest possible success of the performed surgery, it is required to carefully comply with instructions after the surgery and the post-operative rehabilitation protocol. Not SOG.04/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, Tax ID no.:SI29365678 Page | 3 CONSENT Issue| 1 cooperating in the post-operative rehabilitation process could result in a deterioration of the elbow function in comparison with the condition before surgery. Statement of consent to the elbow arthroscopy surgical procedure: In an interview, the doctor has exhaustively and in an intelligible way explained the nature of my elbow injury. For the recommended surgical operation, I received written explanations with information on the expected development and consequences of the elbow disease or injury and with described goals, type, performance method and probability of success and expected benefits of the recommended surgical operation. I have been informed of the advantages and risks and possible complications related to the recommended surgical method of treatment, as well as with other options of continuing treatment. I agree that other required medical personnel can participate in the implementation of the surgical procedure such as an assistant doctor, perioperative nurse and an attendant. I have received satisfactory answers to all my questions; therefore with my signature I am confirming my consent for the performance of the elbow arthroscopy. I have been informed that I have the right to revoke the consent for the recommended procedure at any time. Patient signature:..................................................................................................................................................................................... Signature of the witnesses or statutory representatives:.................................................................................................... Doctor’s name and surname:........................................................ Doctor’s signature:....................................................... Assistant’s name and surname:............................................... Assistants signature:...................................................... Date of consent:............................................................ Time of consent:............................................................... Information forwarding: Persons who I am allowing information regarding my health condition and the course of the planned surgical procedure to be forwarded to: Person 1: Name and surname, relation, phone: …………………………………………………………………......... ……………………………………………………………………........................................................................................................................... Person 2: Name and surname, relation, phone: …………………………………………………………………............... ……………………………………………………………………........................................................................................................................... SOG.04/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, Tax ID no.:SI29365678 Page | 4