Surgery in February 2013
18. Miss I says the treating surgeon should not have used a cross link to extend the rod during her second surgery in February 2013. She believes this contributed to the stress on the screw that later broke, requiring further surgery. She says the surgeon she saw after she had requested a second opinion commented they would not have used this technique as it can lead to the patient developing pseudoarthrosis.
19. The vertebra is series of small bones forming the backbone. The spine is separated into five distinct areas:
• The neck (cervical spine comprising 7 vertebra C1-C7) • Mid back (thoracic spine comprising 12 vertebra T1-T12) • Lower back (lumbar spine comprising 5 vertebrae L1- L5) • The sacrum (comprising 5 vertebra S1-S5) • The coccyx (tail bone comprising between 3-5 vertebra).
20. Miss I’s X-rays from 6 September 2012, show she had a double major scoliosis curve. A double major curve means there are two structural curves in the spine, usually of equal or similar size. Miss I underwent scoliosis correction surgery on 22 September 2012. The purpose of this surgery was to straighten the spine as much as possible by inserting a series of implants consisting of metal rods, screws, and hooks to hold the correction while a bony fusion occurs.
21. Our adviser says Miss I’s post-operative X-rays show there was good correction of the curve and there were no metalwork complications. The X-rays show there were two posterior rods and two cross connectors placed between these two rods. A cross connector is used to connect the two rods together. One was in the mid thoracic spine and one in the lower lumbar spine. Cross connectors share the mechanical load between all the screws and rods on both sides and our adviser says it is a standard technique in this type of surgery.
22. Miss I had further X-ray’s on 17 January 2013 which appear to show one of the rods on the right-hand side had become disconnected from the last screw. There is no obvious fracture of the rod, and our adviser says this is a recognised complication of scoliosis surgery.
23. Miss I had another surgery on 25 February 2013 to correct this. Miss I’s X-rays following the surgery show the rod on the right-hand side has been trimmed and a new rod has been applied from the T12 to L3 vertebra. The cross connector inserted during Miss I’s first surgery appears to have been replaced. There is a domino connector (used to connect the old rod to the new rod) and our adviser says this is a standard technique to use when an implant has failed. Placing a short new rod that is connected to the previous rod means the existing whole rod does not need to be revised completely. This meant Miss I was exposed to less trauma than if the wound was opened and the whole rod was revised to a new construct.
24. A rod can become disconnected from the screw if it is too short or if the mechanism of the screw fails or there is significant mechanical load (physical stress) on the screw and rod. Our adviser says Miss I’s initial postoperative X-ray following her first surgery shows the rod looks captured in the screw and the screw mechanism is intact. It is therefore difficult to see the precise reason why this failed.
25. GMC Good Medical Practice Guidance says:
‘15. You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must:
• adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary • refer a patient to another practitioner when this serves the patient’s needs.
16 In providing clinical care you must:
• prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs • provide effective treatments based on the best available evidence • take all possible steps to alleviate pain and distress whether or not a cure may be possible • consult colleagues where appropriate • respect the patient’s right to seek a second opinion • check that the care or treatment you provide for each patient is compatible with any other treatments the patient is receiving, including (where possible) self-prescribed over-the-counter medications • wherever possible, avoid providing medical care to yourself or anyone with whom you have a close personal relationship’.
26. Our adviser says Miss I’s second surgery in February 2013 was appropriate. There are no specific guidelines which set out what should have happened, but our adviser says this would be the standard of care and surgery expected in the UK. We consider this is line with GMC guidance on providing good clinical care. There may have been a discussion about whether the whole rod should be revised but this is a bigger surgery with an increased recovery, and increased risk of infection by exposing all the metalwork. Our adviser says it is therefore likely most surgeons in the UK would have performed Miss I’s second surgery in the same way.
27. Miss I says her current consultant claims this technique increased her risk of non-union/ psuedoarthrosis. Our adviser says they are not aware of any peer related research that confirms this. The non-union Miss I later presented with is at a much higher level in the spine than where her domino connector was used, so the type of rod/ connector used in this surgery is not relevant to the problem she later developed.
28. We are very sorry to hear about Miss I’s concerns about the technique used during her second surgery in February 2013. From the evidence we have considered so far, we think the treating team acted according to best practice and there is no indication the technique they used was inappropriate or caused her later issues. We hope this provides Miss I with some reassurance.
Diagnosis of stress fracture/ pseudoarthrosis
29. Miss I says there was a delay in the Trust diagnosing her stress fracture/ pseudoarthrosis and during this period she experienced significant pain which had an impact on her quality of life.
30. The Trust say a diagnosis of a stress fracture is extremely difficult to make and the treating surgeon does not think Miss I had a stress fracture. It explains fusions of bone in the spine following correction of scoliosis are subject to force or pressure and sometimes cracks can develop in the fused bone. When this happens, it is formally labelled as non-union rather than a stress fracture albeit sometimes different terminology is used interchangeably. It says it took 15 months to diagnose the non-union as the CT scan did not reveal anything and the non-union was only picked up by a SPECT scan following discussion at an MDT meeting. It says the MDT was not totally convinced this was the cause of Miss I’s pain and suggested a diagnostic injection.
31. A stress fracture is a small crack in the bones and usually happens when there is a lot of repeated force on the bone. Pseudoarthrosis is a term used to describe the outcome of surgery that does not result in a solid fusion of the bones.
32. The records show Miss I had a third surgery on 5 August 2014 because the screw at the same level as before had fractured. The rod was trimmed, and most of the screw was removed. A small portion of the screw remained in the vertebral body (the main portion of the vertebra). Our adviser says this would be the standard of care expected, as the trauma of removing small pieces of screw loose within the vertebral body are not worth the collateral damage that would be needed to remove it.
33. Miss I had further X-ray’s on 10 May 2018 which showed a loosening of other screws, which was not present on her previous X-rays. Miss I had a fourth surgery on 3 June 2018. The postoperative X-ray from 7 June 2018, shows all the screws had been removed except for the fractured screw in the L3 vertebra. Our adviser says Miss I’s spinal alignment looks satisfactory following this surgery.
34. On 29 August 2019, a CT scan to look at the state of the fusion appears to show a solid fusion on the left-hand side of Miss I’s spine and evidence of incomplete fusion on the right-hand side. Our adviser says Miss I’s CT scan and bone scan suggest non-union (pseudoarthrosis) rather than a stress fracture and it would have been extremely difficult to identify these findings when the metalwork was still in situ.
35. Miss I attended an appointment with Dr H and Dr D. In the clinic letter Dr D noted the MDT had discussed Miss I on 23 September and decided she could have a trial of a local anaesthetic diagnostic injection at the level of pseudoarthrosis. The plan was to try conservative treatment with a brace and if she failed to respond to this, they would offer further surgical treatment.
36. Following this Miss I requested a second opinion, and she attended her first appointment with her new consultant Dr O in February 2020. Dr O recorded in the clinic letter that Miss I reported being in a lot of pain and he provisionally added her onto the list for exploration of pseudoarthrosis and stabilisation.
37. Our adviser explains some patients will develop pseudoarthrosis following scoliosis surgery, but this does not necessarily give pain. It was entirely appropriate for this to be assessed with an injection into this area which gave Miss I short but temporary improvement in her symptoms. The multidisciplinary team (MDT) discussed Miss I in a meeting in February 2021. They discussed further intervention given her response to the injection.
38. Our adviser says they have not identified any areas where clinicians did not act appropriately in relation to the pseudoarthrosis. We consider the treating doctors acted in line with paragraphs 15 and 16 of the GMC guidance set out above, as they adequately assessed Miss I’s conditions and arranged appropriate investigations and treatment based on the best available evidence. The complications Miss I suffered from including pseudoarthrosis are recognised complications. She had an implant failure which required a second procedure. She had further implant failure which required an additional surgery. She then developed an infection, the type of which is the most common in teenagers undergoing scoliosis surgery. This loosened her implants and they all needed to be removed in order to get rid of the infection.
39. Our adviser says it appears Miss I developed a non-union and had further surgery to stabilise this. Although it is unusual for patients who undergo this type of surgery for adolescent idiopathic scoliosis to experience persistent pain, it is recognised that a small group of patients will persist with pain in the long-term despite successful looking technical surgery. Our adviser says it appears from Miss I’s X-ray’s and her medical records that the treating clinicians identified and treated these recognised complications appropriately after consideration. As noted above, it would have been very difficult to identify the non-union/ pseudarthrosis when the metalwork was still in situ, and this was appropriately identified after it had been removed and Miss I complained of ongoing pain.
40. The original consent form dated September 2012 documents the risks of failure, repeat surgery and persistent pain. There is some debate about whether non-union causes pain, but our adviser says the treating team appear to have taken appropriate steps in order to try and assess this. There are no specific guidelines available for these complications in adolescent idiopathic scoliosis, but the standard of care provided at the Trust would be the same in other units in the United Kingdom and we consider it acted in line with GMC guidance on providing good clinical care.
41. We are incredibly sorry to hear about the experiences Miss I has had since her first surgery in 2012. We do not doubt this has been an incredibly difficult and distressing time for her as more issues arose and she needed repeated surgeries. We have seen the treating team acted appropriately and identified and treated the non- union/ pseudoarthrosis. We cannot see any indication the pseudoarthrosis and other unfortunate complications Miss I experienced were avoidable or due to any decisions or actions of the treating clinicians for the issues we have investigated.
Appointment 24 October 2019
42. Miss I says she attended spinal clinic with Dr H and another doctor on 24 October 2019. During this consultation Dr H said she had two procedures to which she corrected him, that it is four procedures. She says he excused this by saying he ‘did not dwell on his failures’.
43. The Trust say Dr H has advised he would never refer to a patient as a ‘failure’ and although he cannot recall saying this, he may have been referring to himself, as no surgeon likes to hear that operations they have performed have developed complications.
44. Paragraph 46 of GMC guidance says doctors ‘must be polite and considerate’. We recognise the way in which things are said and how they are meant are open to interpretation and each person involved in the same conversation can come away with a different perception of its contents and what happened. One person’s perception of what was said does not invalidate another person’s opposing perception of the same comment.
45. Whilst we do not dispute Miss I’s recollection, unfortunately, we were not present at the time to independently know what, and how, things were said. We accept Dr H could have said he did not ‘dwell on his failures’. We are left without independent supporting evidence that would indicate to us that a service failure took place.
46. Whilst we do not uphold the complaint overall, we recognise how important this complaint is to Miss I. We thank her for bringing her complaint to us for consideration.