Legally Sound, Evidence-Based Informed Consent Form for Total Hip Arthroplasty

Abstract

Introduction

Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure for obtaining informed consent for total hip arthroplasty (THA). We aimed to develop a solution for this need for a pre-designed, evidence-based informed consent form for THA cases.

Materials and Methods

We extensively reviewed the literature on the medico-legal aspects of THA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in THA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had previously undergone THA in the previous year. Based on all of the above, we developed an informed consent form that was evidence-based. We then had the form reviewed by a legal expert. The final form was utilised for THA cases at our institution for 1 year.

Results

Legally sound, evidence-based Informed Consent Form for Total Hip Arthroplasty is given in Form A.

Conclusion

The use of legally sound, evidence-based informed consent for total hip arthroplasty cases would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, and promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.

Appendix

Annexure 1—Form A—Informed Consent

I, _________________________ hereby authorise the performance of the operation TOTAL HIP ARTHROPLASTY of the ____________ hip joint(s) of ________________________ (Myself/Name of the patient), ________ years of age, with hospital ID _________________.

I have been explained that I/the patient have been diagnosed to have _____________________________________________ since __________years.

I have been informed regarding the other treatment options for the condition including conservative management with analgesics and physiotherapy. I have also discussed other surgical options. After discussion with my doctor, we have decided to proceed with total hip arthroplasty.

I have been explained briefly regarding the steps of the procedure, including the replacement of the head and proximal part of femur and acetabulum with a prosthesis.

I understand that the procedure is being performed to attain a stable, pain-free joint and allow for easier mobilisation than the current condition. However, I also understand that the procedure does not guarantee complete resolution of pain or achieve complete range of movements of the hip joint.

I authorise Dr. _________________________ and such associates and assistants as may be selected by him/her to perform any part of the surgery upon myself/the patient.

I have discussed with the doctor regarding the prosthesis _____________________________________________________________________which is/are planned to be used for the surgery. I am satisfied with the nature and characteristics of the specific prosthesis and approve for the same to be used in the surgery. I have been explained of the possibility of the prosthesis type and design being changed during the surgery after considering the hip condition and anatomy intra-operatively. The fixation of the prosthesis may be cemented, uncemented, or hybrid. The decision on use of cement may be changed intra-operatively if found appropriate. I have been informed that in the event of the prosthesis or cement being found to be faulty, the liability would be with the manufacturer and not the operating surgeon.

I have been explained about the possible requirement for additional procedures like plate/screw/wire fixation for bony reconstruction/fixation of periprosthetic fracture, bone grafting from iliac crest or fibula. I give my consent for such procedures to be carried out in the same surgery if deemed to be required.

I have been explained about the possible complications that can occur during the surgery including, but not restricted to, excessive bleeding, infection, nerve damage, periprosthetic fracture, cement implantation syndrome, damage to femoral or external iliac blood vessels, deep vein thrombosis, pulmonary embolism, etc.

I have been explained about the need for anaesthesia and its potential risks. I have been counselled regarding the benefits and drawbacks of different methods of anaesthesia including general and regional anaesthesia. I consent for the method of anaesthesia to be used as deemed appropriate by the anaesthetist.

I also understand that the surgery may be abandoned at any point during surgery in my own interest, due to anaesthetic complications, implant issues, suspected infection, or other intra-operative complications.

I have also been explained that following the surgery the patient may have limb length discrepancy, incomplete range of movements of the hip, heterotopic ossification, dislocation, periprosthetic fracture, and implant loosening/breakage. The patient may be unable to squat or sit cross legged.

I understand the prosthesis will undergo wear with time. I understand the degree of wear and longevity of the implant will depend on my/the patient’s weight, activities, strain and, therefore, cannot be accurately predicted. Therefore, a revision surgery may be required after a couple of years. I have been told that revision surgery is often complicated and decreases the benefits with each revision.

I understand the prosthesis may be incompatible with different modes of magnetic resonance imaging. This is as per the manufacturer of the prosthesis and is beyond the scope of the surgeon.

I have been counselled regarding the need for physiotherapy and monitored rehabilitation following surgery. I have been made aware of the risk of falls, fractures, and stiffness following the surgery. I have also been informed of the increased risk of complications if I were to not follow the recommendations of the doctors in terms of weight bearing, mobilisation, follow-up visits, post-operative wound care, and physiotherapy.

I give my consent for care in an Intensive Care Unit (ICU) and ventilator support, if the need arises.

I have been informed regarding the possible need for transfusion of blood/blood products preceding/during/following the surgery and give my consent for the same. I have been informed that despite careful screening in accordance with regulations, there are rare instances of infections such as HIV and Hepatitis, or possibility of unpredictable reactions to the transfusion.

I consent to the photography/recording/viewing of the surgery for the purpose of advancing medical education, or its publication in scientific journals/presentations, provided my/the patient’s identity is not revealed in any of the texts/images/videos. I also consent for my data to be entered into national, international registries/databases for knee arthroplasty.

If you wish to specifically opt out of any of the above clauses 16, 17, or 18, kindly indicate it by listing the clause number(s) here ___________.

In the event of an unforeseeable/very rare complication occurring during the surgery, that may warrant a modification of the procedure/additional procedure/abandonment of the procedure, I prefer to (tick one):

Plan it later after my due consent is obtained when I am in a state to make an informed decision (OR)

Authorise for consent to be obtained form ________________________ with Mobile number ___________________ on my behalf.

I have fully read this consent form and comprehend all the above-mentioned points.

OR

This consent has been translated to me to the language of _______________ that I can understand by _____________________ with designation/address _____________________________________________

Signed _________________

I hereby give my consent for the surgery after having fully understood all the above aspects.

Name: ___________________________

Signature: _________________________

Date and Time: ___________________________

If consent is being obtained from someone on behalf of the patient, the reason for inability of patient to sign the consent form _____________________, and relation of individual to the patient___________________________.

Declaration by doctor:

All the above points have been explained in detail to the patient/patient representative prior to surgery.

Name: ________________________

Designation: ______________________

Signature: _______________________

Date and Time: ______________________

Declaration by witness (Optional):

I have been present and witnessed the above said doctor/translator explain the above-mentioned points to the patient/patient representative.

Name: _____________________

Designation/Address: ___________________________

Signature: _____________________

Date and Time: ________________________

Annexure 2—Form B—Informed Consent

I, _________________________ hereby authorise the performance of the operation TOTAL HIP ARTHROPLASTY of the ____________ hip joint(s) of ________________________ (Myself/Name of the patient), ________ years of age, with hospital ID _________________.

I have been explained that I/the patient have been diagnosed to have _____________________________________________ since __________years.

I have been informed regarding the other treatment options for the condition including conservative management with analgesics and physiotherapy. I have also discussed. After discussion with my doctor, we have decided to proceed with total hip arthroplasty.

I have been explained briefly regarding the steps of the procedure, including the replacement of the head and proximal part of femur and acetabulum with a prosthesis.

I understand that the procedure is being performed to attain a stable, pain-free joint and allow for easier mobilisation than the current condition. However, I also understand that the procedure does not guarantee complete resolution of pain or achieve complete range of movements of the hip joint.

I authorise Dr. _________________________ and such associates and assistants as may be selected by him/her to perform any part of the surgery upon myself/the patient.

I have discussed with the doctor regarding the prosthesis _____________________________________________________________________which is/are planned to be used for the surgery. I am satisfied with the nature and characteristics of the specific prosthesis and approve for the same to be used in the surgery. I have been explained of the possibility of the prosthesis type and design being changed during the surgery after considering the hip condition and anatomy intra-operatively. The fixation of the prosthesis may be cemented, uncemented, or hybrid. The decision on use of cement may be changed intra-operatively if found appropriate.

I have been explained about the possible requirement for additional procedures like plate/screw/wire fixation for bony reconstruction/fixation of periprosthetic fracture, bone grafting from iliac crest or fibula. I give my consent for such procedures to be carried out in the same surgery if deemed to be required.

I have been explained about the possible complications that can occur during the surgery including, but not restricted to, excessive bleeding, infection, nerve damage, periprosthetic fracture, cement implantation syndrome, damage to femoral or external iliac blood vessels, deep vein thrombosis, pulmonary embolism, etc.

I have been explained about the need for anaesthesia and its potential risks. I have been counselled regarding the benefits and drawbacks of different methods of anaesthesia including general and regional anaesthesia. I consent for the method of anaesthesia to be used as deemed appropriate by the anaesthetist.

I also understand that the surgery may be abandoned at any point during surgery in my own interest, due to anaesthetic complications, implant issues, suspected infection, or other intra-operative complications.

I have also been explained that following the surgery the patient may have limb length discrepancy, incomplete range of movements of the hip, heterotopic ossification, dislocation, periprosthetic fracture, and implant loosening/breakage. The patient may be unable to squat or sit cross legged.

I understand the prosthesis will undergo wear with time. I understand the degree of wear and longevity of the implant will depend on my/the patient’s weight, activities, strain and therefore cannot be accurately predicted. Therefore, a revision surgery may be required after a couple of years. I have been told that revision surgery is often complicated and decrease the benefits with each revision.

I understand the prosthesis may be incompatible with different modes of magnetic resonance imaging. This is as per the manufacturer of the prosthesis and is beyond the scope of the surgeon.

I have been counselled regarding the need for physiotherapy and monitored rehabilitation following surgery. I have been made aware of the risk of falls, fractures, and stiffness following the surgery.

I give my consent for care in an Intensive Care Unit (ICU) and ventilator support, if the need arises.

I have been informed regarding the possible need for transfusion of blood/blood products preceding/during/following the surgery and give my consent for the same. I have been informed that despite careful screening in accordance with regulations, there are rare instances of infections such as HIV and Hepatitis, or possibility of unpredictable reactions to the transfusion.

I consent to the photography/recording/viewing of the surgery for the purpose of advancing medical education, or its publication in scientific journals/presentations, provided my/the patient’s identity is not revealed in any of the texts/images/videos. I also consent for my data to be entered into national, international registries/databases for knee arthroplasty.

If you wish to specifically opt out of any of the above clauses 16, 17 or 18, kindly indicate it by listing the clause number(s) here ___________.

In the event of an unforeseeable/very rare complication occurring during the surgery, that may warrant a modification of the procedure/additional procedure/abandonment of the procedure, I prefer to (tick one):

Plan it later after my due consent is obtained when I am in a state to make an informed decision (OR)

Authorise for consent to be obtained form ________________________ with Mobile number ___________________ on my behalf.

I have fully read this consent form and comprehend all the above-mentioned points.

OR

This consent has been translated to me to the language of _______________ that I can understand by _____________________ with designation/address _____________________________________________

Signed _________________

I hereby give my consent for the surgery after having fully understood all the above aspects.

Name: ___________________________

Signature: _________________________

Date and Time: ___________________________

If consent is being obtained from someone on behalf of the patient, the reason for inability of patient to sign the consent form _____________________, and relation of individual to the patient___________________________.

Declaration by doctor:

All the above points have been explained in detail to the patient/patient representative prior to surgery.

Name: ________________________

Designation: ______________________

Signature: _______________________

Date and Time: ______________________

Declaration by witness (Optional):

I have been present and witnessed the above said doctor/translator explain the above-mentioned points to the patient/patient representative.

Name: _____________________

Designation/Address: ___________________________

Signature: _____________________

Date and Time: ________________________