Undertaking and Declaration for Total Knee Replacement Surgery by providing informed consent
- Patient Name :
- Surgeon : Dr. Deepak N. Inamdar
- Date :
- Hospital : Apollo Hospital, Jayanagar Bangalore
This undertaking and declaration is made to provide my full and informed consent, given of my own free will, regarding all potential consequences that may arise during and after the total knee replacement surgery. I, ……l̥…………………………………………aged _____, residing at BSK BANGALORE have been informed and explained both in English and my vernacular language by Dr. Deepak N. Inamdar and his team that I am suffering from arthritis of the knee/hip, resulting from wear and tear of the cartilage. I understand that this condition requires treatment to alleviate the severe pain it causes.
I have been informed and explained about the various treatment options available, including non - operative treatment (Non-Surgical Treatment) such as Physiotherapy, Medication and the surgical options such as Robotic Knee Replacement Surgery and Non-Robotic Knee Replacement Surgery and total knee replacement surgery. I have been explained and have understood that I have chosen to undergo the surgical option (Knee Replacement Surgery) out of my free will for treatment of my condition as the previous options have not given me any relief.
I have understood the entire surgical procedure of knee replacement as it is a standard surgery done all over the world. The procedure involves removing the worn portion of cartilage and bone and replacing it with metal/plastic using cement. It involves anaesthesia (local or general) and carries certain risks. I have been offered the operation called Total Knee Replacement Surgery. This is a standard procedure performed worldwide, using artificial materials as implants, some or all of which are fixed to the underlying bone using either cement or cement-less fixation.
I understand that the materials used are very carefully selected and designed for long-term use. Though they are inert and compatible with the body tissues. None of the implants can be guaranteed for indefinite durability. They have been used successfully for over 10-15 years with excellent results in majority of the patients (over 90-95%). However, occasionally there can be wear of the materials leading to loosening of the implant, bone absorption, fracture, and dislocation of the implant and so that I may have to undergo and accept the need for periodic examination by doctor. Very rarely it may be required to do a repeat operation. The results of subsequent operations are similar in quality but may not be as durable and have a higher risk of infection and the load to which the implant is subjected. I further understand that risks are higher in younger, more active and heavy individuals, smokers, those with diseases such as diabetes, kidney failure, liver disease, rheumatoid arthritis, and those who have had previous joint operations. It is necessary for me to follow instructions regarding certain precautions that I must take so that the implant gives me maximum benefit for the longest possible period of time. This includes taking precautions when I undergo any invasive medical, dental or surgical squatting, sitting cross-legged, high impact activities such as jogging/running and following other instructions given to me by my doctor.
I am given to further understand that the dis-advantages of robotic knee replacement surgery is the prolonged duration of surgery, increased risk of infection, pin tract infection, fracture through pin sites which may need for surgery to fix a fracture and the need to convert a robotic to a non-robotic knee replacement during surgery due to robotic software shutdown, computer issues, array issues or implant supply chain issues.
I totally understand that like any major operation, there are certain risks of anaesthesia and surgery. Every safeguard and precaution is taken to ensure a successful operation. However, very rarely there can be some problems. The figures in brackets give me an approximate frequency of complications. These include disturbance or delay in wound healing (5%), infection of the wound (1%), dislocation of the components (1%), deep infection which may require removal of the implants (< than 1%), clots in the veins of the legs (10-30%), retention of urine which may require insertion of catheter for a few days (5%), heart or lung function disturbance(1%), temporary confusion or more rarely a stroke ( 1 in 1000) , disturbance of the digestive system (vomiting, constipation, ulcers) in 10-15% and very rarely life threatening complications (less that 1%). Arterial or vein injury – may require an angioplasty or a bypass graft (0.2 %), persistent pain due to other causes. Blood transfusion is sometimes required and donor blood is carefully screened by the blood bank or compatibility and also to minimize the risk of transmitting infection. In addition, there may be minor problems that occur so rarely that it is not Practice al to describe all of them. However, it is important and I along with my family have realised that precautions and
safeguards are taken to prevent or minimize the risks and the vast majority of patients do not have any significant and safeguards are taken to prevent or minimize the risks and the vast majority of patients do not have any significant complications. Even if complications do occur, usually it is possible to treat most of them but it may require a longer stay or additional treatment(s) and /or consultations. The surgical and nursing staff are aware of these possible problems and every reasonable effort is made to prevent their occurrence. They are also trained to monitor your condition, recognize signs of trouble early and treat quickly to minimize their effects on me.
As a Post-Operative Care and Follow-Up, I accept the need for periodic examinations by my doctor to monitor the condition of the implant. I am aware that following the doctor's instructions regarding precautions (e.g., avoiding certain activities) is crucial for the longevity of the implant. As a formal declaration, I provide my consent for Surgery and Other Medical Procedures. I, the undersigned, hereby authorize Dr. Deepak Inamdar and his associates or assistants to :
- Administer or provide such medical or surgical services, including anaesthesia, as they may consider necessary.
- Administer drugs, infusion, transfusion of blood or blood components, or any other treatment deemed necessary or desirable in the judgement of the medical staff.
- Convert a robotic knee replacement surgery to a non-robotic knee replacement surgery intraoperatively if needed due to bone quality, robot issues, computer shutdown, software shutdown, array issues, or implant supply chain issues or any other reasons during the surgery
As a formal declaration and undertaking towards Data Privacy Consent, I consent to the collection, use, and storage of my personal and medical data in accordance with applicable data privacy laws or the policy of the clinical staff/hospital. I understand that my data will be used for the purposes of my treatment, follow-up, and related medical research or any other medical reasons or requirements as deemed necessary by the medical staff.
I certify that I have read and fully understood this undertaking and declaration. I have been offered the opportunity for further explanations and have received satisfactory answers to all my questions. No guarantee has been made as to the results that may be obtained from the surgery which I fully acknowledge.
I acknowledge and understand the following specific risks associated with the surgery and the circumstances under which they may occur :
- Conversion from Robotic to Non-Robotic Surgery: I understand that the surgery may need to be converted from robotic to nonrobotic due to issues such as poor bone quality, osteoporosis, small bone size (especially in small-built individuals), robot or software malfunctions, array issues, or implant supply chain shortages. In high BMI patients, the increased risk of infection may necessitate a non-robotic approach.
- Risks of Anaesthesia: I understand the general risks associated with anaesthesia, including allergic reactions, respiratory problems, and in rare cases, death.
- Post-Surgical Risks: I understand that post-surgical complications can occur, such as blood clots, infection, implant loosening, nerve damage, and the need for revision surgery. I accept that these risks may require additional medical intervention and potentially a longer hospital stay.
- Long-Term Risks: I understand that despite successful surgery, there is no guarantee of indefinite durability of the implants, and long-term risks include wear of materials, loosening of the implant, bone absorption, fracture, and dislocation.
- Impact of Pre-Existing Conditions: I acknowledge that my pre-existing conditions (e.g., diabetes, kidney failure, liver disease, rheumatoid arthritis) may increase the risk of complications.
- Activity Restrictions: I understand that certain activities (e.g., squatting, sitting cross-legged, high-impact activities) should be avoided post-surgery to prolong the life of the implant.
As a part of Legal Disclaimer and Liability Waiver; By signing this document, I hereby release Dr. Deepak N. Inamdar, his associates, assistants, the hospital/clinic, and all related medical staff from any and all legal liability associated with the total knee replacement surgery and any potential post-operative complications. I understand that every precaution will be taken to ensure my safety and the success of the surgery, but no guarantees can be made regarding the outcomes. I also agree that any disputes arising from this surgery will be resolved through mediation or arbitration, rather than litigation, in accordance with applicable laws.
I confirm that I have had the opportunity to discuss the details of my surgery, including risks, benefits, and alternatives, with Dr. Deepak N. Inamdar. I fully understand and accept the potential risks and outcomes associated with the surgery. I consent to proceed with the total knee replacement surgery under the care of Dr. Deepak N. Inamdar and his team.
Signature of Person Giving Consent :
Signature of Witness :
Name & address of Person Giving Consent :
Name & address of Witness :