Consent procedure – Andrew Manktelow

Details to be discussed at consent for hip surgery

Prior to proceeding with hip surgery you will be asked to sign a form giving consent for hip surgery to go ahead. The issues and possible problems and complications of surgery should all have been discussed with you at the time of your clinic appointment when a decision to proceed with surgery was made. As a further reinforcement of that discussion, I have provided examples below that detail the discussion I have with my patients for each of the hip operations I perform.

For patients undergoing primary total hip replacement:

We will have gone through the procedure itself, the intended benefits and possible concerns.

The benefits of the procedure are to improve pain, to improve mobility and to improve function.

I will have mentioned the risks as well as the potential serious and frequent concerns that surround hip arthroplasty surgery. These include the risk of infection (less than 0.5 per cent), dislocation (1 to 2 per cent), nerve injury (eg foot drop less than 0.5 per cent), weakness or numbness in the leg (I will have mentioned that typically this would be expected to resolve but, very rarely, permanent numbness and weakness can occur), blood clots including the risks of clots in the leg and those that can extend into the lungs (DVT/PE), fracture, bleeding, requirement for revision surgery, leg length inequality, residual pain, wound healing problems, discomfort, implant failure and residual symptoms. We will have discussed the COVID-19- related risk as detailed below.

The patient will have access to the EIDO Healthcare consent information sheets which not only detail the information regarding surgery, potential complications and recovery but also is updated with the latest information regarding the COVID-19 pandemic and related implications on elective orthopaedic surgery. At the same time, I will have directed the patient towards my own website (andrewmanktelow.com) where there is further information that I hope they will find helpful with regard to our plan for hip replacement surgery.

For patients undergoing revision total hip replacement surgery:

We will have gone through the revision procedure itself and my plans for revision and reconstruction.

I will have discussed the intended benefits and possible concerns. The likely benefits of the procedure are to improve pain, to improve mobility and to improve function.

I will have mentioned the risks and potential serious and frequent concerns that surround revision hip arthroplasty surgery. I will have discussed the fact that the risks of revision hip replacement are higher than those that we encounter in primary hip surgery as a consequence of the complexity of implant removal, the surrounding scar tissue and the complex nature of revision surgery. These include the risk of infection (around 1 per cent), dislocation (3 to 4 per cent), nerve injury (eg foot drop less than 0.5 per cent, weakness or numbness in the leg (I will have mentioned that typically this would be expected to resolve but, very rarely, permanent numbness and weakness can occur), blood clots including the risks of clots in the leg and those that can extend into the lungs (DVT/PE), fracture, bleeding, requirement for revision surgery, leg length inequality, residual pain, wound healing problems, discomfort, implant failure and residual symptoms. We will have discussed the COVID-19-related risk as detailed below.

The patient will have access to the EIDO Healthcare consent information sheets which not only detail the information regarding surgery, potential complications and recovery but also are updated with the latest information regarding the COVID-19 pandemic and related implications on elective orthopaedic surgery. At the same time, I will have directed the patient towards my own website (andrewmanktelow.com) where there is further information that I hope patients will find helpful with regard to our plan for revision hip replacement surgery.

For patients undergoing metal-on-metal hip resurfacing:

I will have had a long and detailed discussion about all of the options surrounding hip replacements and hip resurfacings.

With regard to surgery in general, I will have been through things at length. I will have mentioned the risks and potential serious and frequent concerns that surround hip resurfacing surgery. These include the risk of infection (less than 0.5 per cent), dislocation (1-2 per cent), nerve injury (eg foot drop less than 0.5 per cent, weakness or numbness in the leg (I will have mentioned that typically this would be expected to resolve but very rarely permanent numbness and weakness can occur), blood clots including the risks of clots in the leg and those that can extend into the lungs (DVT/PE), fracture, bleeding, requirement for revision surgery, leg length inequality, residual pain, wound healing problems, discomfort, implant failure and residual symptoms. We will have discussed the COVID-19- related risk as detailed below.

With regard to hip resurfacing specifically, I will have explained that this requires a slightly increased surgical exposure to release more soft tissue to allow access, ensuring sound component alignment. I will have explained the slightly increased risks with that from the point of view of infection and slightly slower initial rehabilitation over a more traditional total hip replacement. I will have also explained that, as a consequence of the increased soft tissue exposure, there can be slightly increased concern with regard to nerve injury, discomfort and weakness in the leg. I will have explained that for the first few weeks after the swelling settles, we would expect rehabilitation to push on and indeed for the patient to return to a higher level of activity than would be typical for a hip replacement.

I will have explained the slightly increased risks of early revision with hip resurfacing, specifically including early femoral neck fracture. I will have explained that if there is any concern with bone quality found at the time, or with component alignment, we would not proceed with the operation and would convert to a slightly more traditional approach, likely using an uncemented fixation with 36mm ceramic-on-crosslink polyethylene bearing, by which we would expect to obtain a sound, stable reconstruction and allow sound return to activity.

In the absence of femoral neck fracture, I will have explained that a well-positioned metal-metal hip resurfacing in gentlemen would be expected to give a 90 per cent survival at 15 years. If there were concerns, one could consider conversion to a total hip replacement.

Against that background, I will have explained the issues surrounding metal-metal wear and the concerns that have been raised with slightly elevated levels of cobalt and chromium following the implantation of these devices. I will have explained that we would check blood metal ion levels at a year, five, seven and ten years and, beyond that, as per MHRA guidance. Again, I will have reassured the patient about the results with the BHR and Adept® metal-metal implants which are the implants that I have used, here in Nottingham, with sound results. I will have explained that many of the more major metal-metal concerns have come with other implants and, specifically, with large head metal-metal hip replacements.

Given the patient’s age, activity profile and bone quality, I will have explained that I do think that hip resurfacing would be an option. The patient will have been made aware of the possibility of requiring hip replacement, as detailed above, and I will have explained that we will do all we can to improve hip function and return the patient to a good level of activity with hip surgery with risks as discussed.

For patients undergoing ceramic-ceramic hip resurfacing with the ReCerf™:

I will have had a long and detailed discussion about all of the options surrounding hip replacements and hip resurfacings.

With regard to surgery in general, I will have been through things at length. I will have mentioned the risks, potential serious and frequent concerns that surround hip resurfacing surgery. These include the risk of infection (less than 0.5 per cent), dislocation (1 to 2 per cent), nerve injury (eg foot drop less than 0.5 per cent), weakness or numbness in the leg (I will have mentioned that typically this would be expected to resolve but, very rarely, permanent numbness and weakness can occur), blood clots including the risks of clots in the leg and those that can extend into the lungs (DVT/PE), fracture, bleeding, requirement for revision surgery, leg length inequality, residual pain, wound healing problems, discomfort, implant failure and residual symptoms. We will have discussed the COVID-19-related risk as detailed below.

With regard to hip resurfacing specifically, I will have explained that this requires a slightly increased surgical exposure to release more soft tissue to allow access, ensuring sound component alignment. I will have explained the slightly increased risks over that from the point of view of infection and slightly slower initial rehabilitation than a more traditional total hip replacement. I will have also explained that, as a consequence of the increased soft tissue exposure, there can be slightly increased concern with regard to nerve injury, discomfort and weakness in the leg. I will have explained that for the first few weeks after the swelling settles, we would expect rehabilitation to push on and indeed for the patient to return to a higher level of activity than would be typical for a hip replacement.

In the absence of femoral neck fracture, the other major concern with previous metal-metal hip resurfacing devices was an abnormal wear process that could give rise to elevated levels of cobalt and chromium locally and systemically. Results in women and in patients with small hips were not as rewarding or as reliable as those in men and in larger hips. The use of metal-metal hip resurfacing was therefore discontinued for those patient groups.

More recently, there have been developments with regard to a ceramic-ceramic hip resurfacing device, the ReCerf™, and we will have discussed that in clinic.

I will have explained that there have been around 500 implantations of this device, some now coming towards four years from surgery. The implant is functioning well and while there have been five revisions, only one has been directly related to the implant itself. I was involved in the first implantation of this device in the UK in Newcastle and we have since used the ReCerf™ implant in Nottingham. We are running an important evaluation study into which the patient would be entered, based here in Nottingham, but with other centres around the UK including Oxford, Newcastle, Glasgow, Bristol, Cambridge and London, contributing to that analysis. The study will involve clinical and physiological measures in patient reported outcome scores as well as a review and evaluation of x-rays. The results of the study will be used in the process of evaluation to determine whether the implant can be released to a wider orthopaedic audience.

I will have provided the patient with all of the relevant documentation for this study including the patient information sheet. I will have been through the specific consent form relating to the patient information that is required and, indeed, I will have been through the surgical consent form.

In addition to the issues that surround metal-metal hip resurfacing, the additional concerns with the ReCerf™ being ceramic are the theoretical concerns of noises and squeaks that have occurred in other ceramic bearings, though this has not been a concern with the ReCerf™ to date.

With regard to benefits, patients are made fully aware of the theoretical benefits of hip resurfacing including reduced dislocation rate, more physiological loading of the proximal femur and the ability for them to return to some of their more demanding physical activities.

General information relevant to Covid and patients undergoing hip surgery:

We will have had a discussion regarding the concerns that surround elective hip surgery within the COVID environment. We will also have had a long discussion including other potential management options, including non-operative treatment and indeed the possibility of deferring surgery. We will have discussed the pathways designed to allow elective surgery to proceed, including the requirement for a period of self-isolation before and after the surgery and the likely testing and screening that would be involved before the procedure.

We will have discussed concerns of contracting COVID-19 infection peri or post-operatively and the possible clinical implications of chest and other conditions. We will have discussed the possibility of additional morbidity, and indeed mortality, that could result and we will have discussed the overall local death rate in cancer patients having surgery during the Covid pandemic which has been estimated at less than 1 per cent.

Elective orthopaedic pathways have been designed based on existing processes and protocols to ensure that we do all we can to protect joint replacement patients as they approach and proceed through surgery.