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CONSENT Issue| 1 CONSENT FORM FOR ARTHROSCOPIC RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT Present witnesses (fill out in case of oral consent in case of inability for written consent): Witness 1: Name and surname, Unique citizen identification number - EMŠO: .......................................................................................................................................................................................................................... Witness 2: Name and surname, Unique citizen identification number - EMŠO: ......................................................................................................................................................................................................................... Reasons for inability or refusal for written consent: ..…………………………………………………………………………………………………………………………………………......................... Affected side: Right Left Description of the surgical procedure (a detailed description is enclosed in the information for patients): 1. The surgical procedure is done under general anaesthesia. The anaesthesia procedure, risks and complications related to anaesthesia are described in detail in the Anaesthesia consent form. If you have any question, the anaesthetist specialist who is going to perform this procedure, will answer them. 2. During the surgical procedure, an endoscopic video camera is inserted into the knee joint which enables the examination of it. 3. During the surgical procedure, a camera is used to examine joint structures such as cartilage, cruciate ligaments, meniscus and the kneecap. 4. If during the arthroscopy it is determined that there exist other injuries besides the torn crucial ligament, these are treated with a suitable surgical procedure if it is possible and reasonable. 5. With menisci injuries this can mean partial or entire removal, in some cases also the stitching of the meniscus. 6. With cartilage damage, depending of the extent of the damage, the surgeon can perform smoothing of the cartilage, microfracturing (slightly drilling or breaking the bone where there SOG.06/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, D.Š.: SI29365678 Page | 1 CONSENT 7. 8. 9. 10. 11. 12. Issue| 1 the cartilage is damaged), rarely also autologous osteochondral transplantation. The extend of the cartilage damage may also be such that an additional surgical procedure is needed. In rare cases, when the wearing out of cartilage surfaces in the joint is in an advance stage, the surgeon may decide not the carry out the reconstruction of the cruciate ligament. Smaller changes on the cartilage usually do not require special treatment. During diagnostic arthroscopy it can be determined that the anterior cruciate ligament is only stretched or slightly torn. In this case, the surgeon can decide for its reinforcement, its complete replacement with a new ligament or not to carry out the planned procedure at all. In some cases regionally restricted blood flow, which is achieved with a pressure band placed on the thigh, is needed during the procedure in order to attain a better overview of the joint. The reconstruction of the cruciate ligament is done with an autologous tendon graft from the Semitendinosus or Gracilis muscle which is harvested from the rear part of the thigh, usually on the treated leg, or by harvesting the middle third of the kneecap tendon. With patients who already had previous surgery on their knees or with patients who had several tendons torn, alologous tendon grafts can be used. In this case, the harvesting of the patient’s own tendons is not necessary. After performing diagnostic arthroscopy and treating possible accompanying injuries in the joint, the harvesting of the tendon graft is done. When using the Semitendinosus and Gracilis tendons, an additional, a few centimeters long incision is made along the tendon-bone junction of the Semitendinosus and Gracilis on the inner side of the upper part of the shank. When harvesting the kneecap tendon, a few centimeters long incision is made above the kneecap tendon in the middle of the knee. After harvesting the tendon graft, the position of the bone tunnels in the shinbone and thighbone, through which the new tendon is going to run, is determined with the help of the arhtroscope. Through these tunnels a leading stitch is initiated, which is then used for installing the tendon graft. This is followed by the fixing of the tendon graft, first in the tunnel on the thighbone and then also in the tunnel of the shinbone. The method of fixing depends on the type of the used tendon graft and the used surgical technique. Different interference screws can be used. A titanium button can be used for fixing to the thighbone. Before the procedure, the surgeon will inform you about the method of fixing the cruciate ligament in your case. The surgical procedure lasts from 1 to 2 hours, depending on the complexity and accompanying injuries of the joint. Immediately after the procedure you will for a short time lie in the recovery room. After the procedure, the patient receives instructions for post-operative treatment and an appropriate analgesic therapy is prescribed. You are dismissed on the same day, escorted home by another person. Expected benefits of the proposed surgical procedure: 1. Improved knee stability. 2. Reduced risk for later development of knee injuries. 3. Reduced risk for repeated knee injuries with cartilage damage and menisci injuries. SOG.06/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, D.Š.: SI29365678 Page | 2 CONSENT Issue| 1 The measure in which you can expect the above mentioned benefits in contrast with the pre-operative state of the knee joint and possible accompanying injuries, will be presented to you by the doctor performing the surgical procedure. Notes of the doctor who performed the explanatory duty: …………………………………………………………………………………………………………………………………………………………….. …………………………………………………………………………………………………………………………………………………………….. …………………………………………………………………………………………………………………………………………………………….. Risks connected with the proposed surgical procedure: 1. Every surgical procedure can cause unwanted bleeding outside the part of the performed procedure. Probability than an arthroscopic procedure will cause a major bleeding which would require hospital treatment and transfusion is extremely small. 2. After every surgical procedure there can occur a bacterial infection which can cause festering of the wound and a bacterial infection of the joint. In order to reduce the risk of pre-operative infection, the patient receives preventative antibiotics. If an infection of the joint or the wound does occur, a long-term treatment with antibiotics is needed. In some cases one or more additional surgical treatment with rinsing the joint and removing the festered or infected soft tissue. In the case of a reconstructed anterior cruciate ligament, a bacterial infection in the knee can cause the decay of the reconstructed ligament and the need to remove the died away or infected ligament. 3. During a diagnostic arthroscopic examination of the joint, unexpected injuries can be discovered in the joint which can require additional surgical procedures. 4. Reoccurrence of the problems. Although arthroscopic procedures on the knee are generally very successful, we cannot completely assure you that all problems will be successfully dealt with. Though the surgical procedure is professionally and perfectly carried out, the problems can persist after the procedure, they can reoccur or even in some rare cases increase. 5. Reoccurrence of a torn cruciate ligament. This can occur in case of a new injury, extremely rarely due to a not completely optimal course of the bone tunnels. The reconstructed cruciate ligament can also get torn at lower strains. Excessive scarring of soft tissue in the region of the reconstructed cruciate ligament can cause limited mobility of the knee with the inability to completely extend the knee. This requires an additional surgery, usually to remove the scarred part, in rare cases to re-reconstruct the cruciate ligament. 6. Nerve, vein, ligament or muscle damage in the knee joint. These injuries are extremely rare but they can still occur. In case they do occur, the injuries are in rare cases permanent. Such an injury can cause the loss of power in a certain part of the leg or knee, the loss of the sense for touch, the loss of leg or knee usability, or chronic pain in the leg or knee. Possible pre-operative nerve damage does not improve after the surgical procedure, in some cases they can get worse. After the surgery there can be a sensation of burning pain, tingling or oversensitivity. 7. Complications connected with instruments. Instruments such as a video camera, a tissue razor, different sensors and clamps can break in the joint, parts of the instruments can break off and stay in the joint. This can require the removal of a broken part of the instrument from the joint. Such parts of instruments can also cause joint injury which can be severe and permanent. 8. After the surgical procedure, a chronic pain can develop in the joint. 9. Weakening of the muscles and limited joint mobility. This does not occur directly because of the procedure but because of inappropriate rehabilitation. Long-term limited joint mobility and/or weakening of the muscles can cause the prolonging of post-operative rehabilitation and in rare SOG.06/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, D.Š.: SI29365678 Page | 3 CONSENT Issue| 1 cases additional surgical procedure. Hardening of the joint and reduced muscles power can also be permanent. 10. Knee arthroscopy is a surgical procedure in which technologically advanced surgical equipment is used. Despite using the best and high-quality medical equipment, which is made in compliance with all safety standards, there can be a breakdown of the equipment during the surgery. This can in rare cases prevent the planned surgical procedure and the cancelling of the surgery. In this case an additional surgery can be needed due to this or the entire surgical procedure must be repeated. 11. Because of the pressure band on the thigh which is used to reduce the blood flow in the knee and improve the overview of the surgical field, there can occur some superficial skin injuries, including redness, abrasion and wounds. Due to leaking of the disinfectant under the pressure band positioned on the thigh which is used to disinfect the skin on the knee before the operation, there exists a possibility that, despite carefully placing the pressure band, an allergic reaction or disinfection irritation can occur under it, which can lead to superficial chemical burns of the skin. 12. Risks and complications connected with anaesthesia are explained in the Anaesthesia consent form. Although it is extremely unlikely, it is still possible that there occur complications such as cardiac arrest, a stroke, the development of blood clots with consequently clogged veins and even death during or after the surgery. The risk for the development of such occurrences depends on the patient’s general health condition, age and other accompanying diseases. Any of these complications can occur with or without any preceding warning signs. Raised blood pressure, diabetes, age over 65, a recovery from cardiac arrest, recovery from conditions with blood clots, female hormone contraception, recovery from a stroke, smoking, previous surgical procedures on the heart are only some of the conditions which increase the risk for some of the above mentioned complications. Everyone is different and everyone has some additional risk factors due to their health condition, lifestyle or the level of physical activity. Risk factors for during or post-operative complications are in your case the following: (circles the doctor): 1. 2. 3. 4. 5. 6. 7. Diabetes Smoking Obesity Generally bad physical condition Excessive drinking Age over 65 Other: ………………………………………………………………………………………………………… Other options for treatment: 1. You can accept that you have an injured knee and get used to limited knee functionality. 2. You can continue with physical therapy which will somewhat improve knee functionality when the thigh muscles are strengthened. 3. You can permanently use a 4-point knee brace which will at least partly reduce the problems related with the instability of the knee. Post-operative plan: The surgical procedure is only one part of the treatment of your knee. After the surgical procedure, a long-term intensive physical therapy is needed, which must in the case of the reconstruction of the SOG.06/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, D.Š.: SI29365678 Page | 4 CONSENT Issue| 1 anterior cruciate ligament last up to six months after the surgery. In order to improve the success of the performed surgical procedure, the instructions after it have to be carefully followed, as well as the postoperative rehabilitation protocol. Noncooperation in the process of post-operative rehabilitation has for its consequence the worsening of the knee functionality in comparison to the state before the surgery. Statement of consent for a surgical procedure – arthroscopic reconstruction of the anterior cruciate ligament The doctor has in person explained in detail and in an understandable way the nature of my knee injury. For the proposed surgical procedure I have received written explanations with information about the expected development and consequences of the disease or knee injury with described goals, sort and method of the procedure and the probability of success and expected benefits of the proposed surgical procedure. I am familiarized with the benefits, risks and possible complications which are connected with the proposed surgical treatment, as well as with other options for treatment. I agree that other needed medical staff such as a physician assistant, a surgical nurse and attendant take part in the surgical procedure. All my questions have been answered satisfactorily. Therefore by signing this statement I consent to a surgical procedure – arthroscopic reconstruction of the anterior cruciate ligament. I know that I have the right to revoke the consent for the proposed procedure at any given 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 for whom I am allowing the information to be forwarded to regarding my health condition and the course of the planned surgical procedure: Person 1: Name and surname, relation, phone: …………………………………………………………………………………….. ……………………………………………………………………........................................................................................................................... Person 2: Name and surname, relation, phone: …………………………………………………………………............................ ……………………………………………………………………........................................................................................................................... SOG.06/10 Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, D.Š.: SI29365678 Page | 5