3. Mr E complains the Trust incorrectly did a total knee replacement (TKR) on his right knee on 5 July 2021. He complains that from July to November 2021, the Trust did not take his concerns about complications seriously and would not refer him for revision surgery.
4. Mr E says he was in pain and discomfort for 19 months and not being taken seriously caused him distress. He now needs more surgery and there is a risk of amputation.
5. Mr E wants an apology from the Trust.
6. In 2019 Mr E had a high tibial osteotomy (surgery to realign the knee joint) for his arthritis. The operation failed in his right knee causing pain, swelling and limited movement.
7. On 5 July 2021, the Trust did a TKR in his right knee. Surgeon A did this.
8. On 27 July, surgeon A assessed him. Mr E heard noise when he moved his knee and it was swollen.
9. Between 14 and 16 August he went to A&E and surgeon A reviewed him. The Trust took X-rays and did a blood test.
10. Surgeon A’s 9 November assessment noted Mr E was still feeling pain, sensations of instability, clunking, numbness and swelling. Surgeon A referred him for a second opinion.
11. On 21 March 2022, surgeon B assessed Mr E and reviewed a recent X-ray. Surgeon B assessed him again on 16 May, 4 August and 13 October. During this time surgeon B noted the blood test showed no sign of infection and X-rays showed no sign of loosening. Surgeon B removed 40mls of fluid from his knee. They tried a brace for additional support recommended at a multi disciplinary team meeting (an MDT is when healthcare professionals from different areas of medicine meet and discuss patient’s needs). Surgeon B then referred him for a third opinion.
12. On 16 November surgeon C assessed Mr E. Surgeon C thought there was increased laxity (a measure of looseness) under stress and bending. They noted recent X-rays did not show obvious loosening or other issues and there was no sign of infection. On 6 December surgeon C removed more fluid from Mr E’s knee and did an X-ray alignment check, which they said showed instability.
13. On 18 January, surgeon C diagnosed Mr E with pain and instability in his TKR. They put him on the waiting list for a revision TKR.
17. Before we decide if we should do a detailed investigation of a complaint, we look at whether there are signs the organisation got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not seen any signs that something has gone wrong.
18. We will first consider the TKR surgery on 5 July 2021. Mr E complained the Trust did this incorrectly. He told us this is because of the noise the replacement made and the jolting he felt. We are sorry to hear of the pain and discomfort Mr E experienced and is still experiencing. We are also sorry to hear of the mental distress this caused him.
19. The BOA guide to TKRs explains the surgery is done in several stages. A cut is made down the front of the knee. The replacement is then fitted after the bones are shaped to form a tight fit with the new joint. One way for the replacement to be attached is to use bone cement.
20. Mr E’s TKR was a Stryker triathlon knee replacement. Stryker produce a surgical guide for surgeons doing TKRs with its medical devices.
21. The study in the Journal of Orthopaedic Surgery and Research explains the most common causes of instability after TKRs. There can be patient specific factors like traumatic falls or genetic tissue disorders and implant-related factors to do with design, wear, or settling of implants. Technique specific factors include misalignment, issues with rotation or issues with bone cutting.
22. The Trust’s operation notes record every step it takes during the TKR, including the preparations and cuts made to both skin and bone. The notes explain how it measured the bone and replacement for fit, and then fitted and tested the replacement. We can see from the notes made at the time of surgery that the knee could extend and flex up to 120 degrees without detaching and was well aligned.
23. Our adviser reviewed the Trust’s surgical technique against the Stryker surgical guide. They said the Trust used an appropriate surgical technique in line with Stryker’s guide for its knee replacements. They saw no sign that anything went wrong with the TKR.
24. We have not seen anything to suggest the Trust did not do the TKR in line with guidance. While surgeon C identified that Mr E had instability in his TKR, they did not find a specific cause for this.
25. Mr E also complains the Trust did not take his concerns about complications seriously and would not refer him for revision surgery.
26. BOA guidelines for problematic knee replacements say first investigations should include a clinical examination, X-rays and screening to check for infection. It says a referral to a regional MDT is recommended. It says bone scans and minor operations are not routine in this situation.
27. The BOA guide for TKRs says loosening can be a specific risk of complication. It explains with loosening, ‘the new joint may become loose where the metal or cement meets the bone. This can cause pain and eventually another operation is needed’. The Trust’s operation consent form also highlights this risk.
28. Laxity is a measure of looseness. Our adviser explained there is always a certain amount of laxity after a TKR, and in many cases this does not cause the patient pain. Sometimes loosening or laxity can cause a feeling of instability. The assessment of instability is down to clinical judgement. There is no general clinical agreement on what level of instability is an issue.
29. The article in the Journal of Orthopaedic Surgery and Research explains that instability usually happens when pulling the leg in a certain way and comparing the movement around the knee on each side. It notes often this is classified based on level of movement as: mild at less than 5mm, moderate at less than 10mm and marked at more than 10mm. However, it notes there is no general professional agreement on this.
30. The article in the Journal of the American Academy of Orthopaedic Surgeons explains manual testing for laxity is done to confirm a diagnosis, but testing positions and laxity grades are inconsistent.
31. We can see from the clinical records that the Trust examined the knee in July, August and November 2021. It did not find a specific cause for Mr E’s pain or feeling of instability. It did X-rays on 6 July, 14 August and 8 October. The Trust noted none of these showed any signs of abnormal laxity or instability. The Trust took a blood test in August and there was no sign of infection.
32. Our adviser said instability does not often show on X-rays. They explained there is no specific investigation or reliable way to measure this, so diagnosis is down to clinical judgement.
33. We are only considering the Trust’s first period of investigation (to November 2021). Because there is no subjective way to measure instability, we think it is helpful to describe the Trust’s other clinical judgements of Mr E’s TKR. We note none of the three surgeons found any issues with the TKR from standard X-rays. Surgeon B did not find any specific cause of Mr E’s issues and while surgeon C diagnosed Mr E with instability, they did not find a specific cause for this.
34. BOA guidelines for revision TKR surgery say the decision for revision surgery should be based on a specific cause for the issue. Where a specific cause for the issue has not been found, patients should be discussed at the MDT because there is a lower chance the surgery will benefit the patient. It notes in some patients no specific cause for their issue will be found.
35. The study in the Journal of the American Academy of Orthopaedic Surgeons explains patient outcomes after revision TKR are lowest for instability compared to other types of complications.
36. Surgeon B gave a second opinion on Mr E’s TKR and when they also did not find a specific cause for the issue, the case was referred to the local MDT meeting in line with national guidance. The MDT recommended trying a brace. The MDT did not agree that revision surgery was the right course of action. We cannot see any suggestion in guidance or research that the Trust should have referred Mr E for revision surgery at this time because it had not found a specific cause, and the MDT could not reach an agreement.
37. Surgeon C firstly felt there was some laxity and from the standard X-rays he was not sure if this was causing Mr E’s symptoms. They did an alignment check, or video X-ray. Using this they found definite instability under stressing but did not note a specific cause for it.
38. Alignment checks are not part of the recommended investigations in national guidance and, as suggested by research, there is limited evidence for their use in this situation. For this reason we cannot say the Trust should have considered doing an alignment check sooner.
39. The study in Clinical Orthopaedics and Related Research explains 27% of all patients having knee replacements reported hearing grinding, popping or clicking from the knee after surgery.
40. As suggested by this research, our adviser said noises are a recognised outcome. They told us clicking noises are not a sign of an issue or instability. The Trust reviewed the noise from Mr E’s knee and did not see this as a concern. Our adviser explained the noise itself would not be a sign that revision surgery is needed.
41. British Medical Journal research found 20% of patients had chronic pain after a TKR, and a specific cause could not be found in all of these cases. The study in the Journal of Bone and Joint Surgery also found ten to 20% of patients report pain, stiffness and dissatisfaction after surgery.
42. We have reviewed every record of the Trust’s assessments after surgery. We can see each time it took Mr E’s concerns seriously and investigated them in a way that was in line with relevant guidance. We have seen nothing to suggest the Trust did anything wrong in response to Mr E’s concerns. Sadly, as suggested in the above research, pain and laxity are recognised complications of TKRs. We are aware Mr E is currently waiting for a revision TKR and we hope this goes well for him.
1. We have carefully considered Mr E’s complaint about Gateshead Health NHS Foundation Trust (the Trust). We are sorry to hear about the pain and discomfort in his knee after surgery.
2. We have decided to take no further action on this complaint because we have seen no sign that anything went wrong. We are satisfied the Trust acted in line with guidance in the decisions it made. We explain the reasons for our decision in this statement.