CONSENT
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INFORMED CONSENT FOR SHOULDER ARTHROSCOPY
Witnesses present(to be filled out only 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 onlyif 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:
Reconstruction of rotator cuff
Subacromial decompression
Tenodesis of the long head of the biceps tendon
Resection of the distal part of the clavicle
Shoulder stabilisation
AC joint stabilisation
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.
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2. During the surgery, an endoscopic optical instrument with a camera is inserted into the shoulder
joint, which enables the examination of the inside of the joint.
3. The endoscopic camera is used to examine the joint structures such as cartilage, rotator cuff
tendons, thelong head of the biceps tendon, labrum and the glenohumeral ligaments.
4. Structures found to be damaged or changed are repaired with a suitable procedure such as
resewing up or fastening to the bone 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.
6. In some cases, the end part of the clavicle that was changed by degeneration must be removed
since this can cause pain in the shoulder joint.
Expected benefits of the recommended surgery:
1. Elimination or decrease of pain in the shoulder
2. Improved range of active shoulder mobility
3. Improved strength of abduction in the shoulder
You will find out theextent you can expect the above benefits related to the surgery depending on the
pre-surgery condition of the shoulder 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 shoulder
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 shoulder 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 or shoulder, loss of the sense of touch, loss of the use of the arm or shoulder or
chronic pain in the shoulder or arm. Any pre-existing nerve damage does not improve after such
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Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, Tax ID no.:SI29365678
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CONSENT
6.
7.
8.
9.
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a surgical procedure or may even deteriorate. After the surgery, a feeling of burning pain,
paraesthesia or hypersensitivity may develop.
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
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 shoulder 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 shoulder injury and get used to the limited shoulder function.
2. You can continue physical therapy, which in time may somewhat mitigate your issues with the
shoulder or improve the shoulder function.
3. Local interventions with corticosteroid, 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 the shoulder.
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Post-surgery plan:
The surgical procedure is only a part of the process of treating your shoulder injury. After the surgery, a
longer period of intensive physical therapy will be required that in some cases must last up to 6 months
after surgery. To ensure the highest possible success of the performed surgery, it is required to carefully
comply with the instructions after the surgery and the post-operative rehabilitation protocol. Not
cooperating in the post-operative rehabilitation process could result in a deterioration of the shoulder
function in comparison with the condition before surgery.
Statement of consent to the shoulder arthroscopy surgical procedure:
In an interview, the doctor has exhaustively and in an intelligible way explained the nature of my
shoulder injury. For the recommended surgical operation, I received written explanations with
information on the expected development and consequences of the shoulder 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 shoulder arthroscopy. I have been informed that I
have the right to revoke the consent for the recommended procedure at any time.
Final provisions:
For all potential disputes that could evolve from the present intervention, both parties agree that the
subject - matter and territorial jurisdiction of the court exclusively follows the location of the medical
intervention, excluding any rules that set a different local jurisdiction.
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:...........................................................
Forwarding information:
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: …………………………………………………………………...............
……………………………………………………………………...........................................................................................................................
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Artros d.o.o, Tehnološki park 21, 1000 Ljubljana, Tax ID no.:SI29365678
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