The 2020 NICE guidelines for primary hip, knee and shoulder replacement: key recommendations and the ongoing need for better quality evidence in orthopaedics

Paul Baker, Ananth Ebinesan, John Skinner, Andrew Metcalfe and Jonathan Rees

Why should orthopaedic surgeons engage in the development of NICE Guidelines?

The development of a NICE guideline is viewed as rigorous and independent. As such published guidelines are supported and endorsed by NHS England and have a greater impact than guidelines from specialist societies. For this reason, when a new orthopaedic NICE guideline is proposed, it is critical we engage to ensure there is orthopaedic expertise on the guideline committee. However, this can be challenging as there are no ‘nominations’ and surgeons do not represent the BOA or their specialist society. The surgeon must apply independently, fulfil various criteria, pass an interview and be prepared for guideline commitments that take 2-3 years to compete. Despite these hurdles, we would encourage BOA members looking for new challenges and wishing to make a national contribution to patients and the health service to apply.

In the instance of the new hip, knee and shoulder replacement guidelines, the sheer breadth of a combined guideline encouraged the authors to apply as we recognised the importance of the topic, and the need to ensure correct clinical interpretation of the evidence in making recommendations that could have profound effects on patients and joint replacement services. Once appointed to a NICE guideline committee, a detailed scope is first developed. Many will ask why this guideline complicates matters by combining all three joints. This topic was picked by NHS England, not NICE, and not the committee.

Due to the large remit of this guideline, we structured it as a patient pathway from the point of offering joint replacement. The scope went out for public consultation in March 2018 and was finalised by NICE in April 2018. Multiple systematic evidence reviews were then conducted for each question assessing clinical and cost effectiveness. It is worth noting that while some of us are involved in large joint registry data research, this is not considered in the NICE process even though many will consider registry data to be highly relevant to this topic. NICE deal with RCT evidence and the evidence reviews are detailed and of high quality. The meetings we attended were intense and long with many challenging discussions. In total it took 2.5 years to complete this guideline which has produced 24 final recommendations. Importantly for those of you active in high quality research, it has also produced 16 research recommendations.

The full guidelines and committee discussions can be found at www.nice.org.uk/guidance/ ng157, but we present the main highlights for you by speciality.

How will these guidelines effect you and your Trust?

For hip, knee, shoulder surgeons and hospital trusts

Preventing infection in all patients: No evidence was identified to justify adding antiseptics or antibiotics to saline wash for wound washouts and so NICE guidance NG125 (www.nice.org.uk/guidance/ng125) on surgical site infection should be followed. A recommendation to use ultraclean air theatre ventilation systems for primary hip, knee and shoulder replacement surgery was also made.

Avoiding implant selection errors in all patients: It is recommended that surgeons now use two intraoperative stop moments, one before implantation and one before wound closure to ensure correct implant details and compatibility. A recommendations was also given to consider intraoperative real time data entry before implantation using systems that provides an alert to any mismatch. A research recommendation was also made on the topic.

Post-operative rehabilitation: While an inpatient, a physiotherapist or occupational therapist should offer rehabilitation on the day of surgery if possible, and no more than 24 hours after surgery. Before patients leave hospital a physiotherapist or occupational therapist should give advice on self-directed rehab. For shoulder patients, additional advice on supervised group rehab or individual rehab should also be offered.

Follow up and monitoring: No recommendations were made on this topic with no evidence identified during the review process.

For hip surgeons and hospital trusts providing hip replacement surgery

This current NICE guideline supplements the 2014 NICE technology appraisal for hips (TA 304), which produced ‘recommendations on artificial hips and hip resurfacing for treating end stage arthritis of the hip in adults.’ The 2020 guideline did not revisit the topics of this appraisal but instead expanded the recommendations related to hip replacement by exploring the following new topic areas.

Pre-operative rehabilitation: Evidence from non-NHS settings showed the value of pre-operative rehabilitation. It is important to recognise that pre-operative rehabilitation includes not only information about exercises to undertake prior to surgery but also information about lifestyle changes, health management, maintaining independence and maximising wellbeing after surgery. It reflects a holistic approach to patient care and an opportunity to grasp the ‘teachable moment’ around surgery when patients may be open to broader interventions that address their health needs. While the content of ‘prehabilitation’ was broadly defined, the format, timing and delivery of this intervention was not, allowing individual centres to introduce this intervention in a way that integrates with their current service. It also led to a research recommendation to best define how, when and where prehabilitation should be delivered.

Tranexamic acid: There was an abundance of evidence supporting the use of tranexamic acid. This cheap intervention reduces blood loss and transfusion requirement and should be used both at induction of anaesthesia and topically during the procedure for maximal effect.

Anaesthesia: NICE has recommended the use of either general or regional anaesthesia in combination with local infiltration anaesthesia (LIA). The evidence supported a multimodal anaesthetic approach and LIA or nerve blocks were found to be equally effective when combined with a general or regional anaesthetic. Using the two together produced no additional benefit and the committee therefore recommended LIA in preference to nerve block given the reduced time and cost associated with this procedure.

Surgical approaches for hip replacement: There was a lack of high-quality evidence supporting one approach over another and the recommendation therefore supported the use of three established hip approaches (posterior, anterolateral and anterior). Due to the lack of evidence, newer approaches such as the direct superior and SuperPATH could not be recommended and were instead included in a research recommendation.

For knee surgeons and hospital trusts providing knee replacements

Pre-operative rehabilitation: For knee replacement as with hip replacement, there was good data on multi-modal pre-operative rehabilitation.

Anaesthesia: Regional or general anaesthetics were both considered acceptable and should be used with local anaesthetic infiltration for all cases. A nerve block could be used in combination with this if it takes up a relatively short period of theatre time (no more than 10 minutes) but the evidence was not conclusive on this.

Tranexamic acid: There was good data on the use of combined systemic and topical tranexamic acid during knee replacement.

Partial or total knee replacement: For people with isolated medial compartment osteoarthritis, the evidence demonstrated benefits for partial knee replacement in some outcomes, such as early pain, satisfaction, and rates of VTE, but also benefits for total knee replacement for other outcomes, such as need for revision. The non-surgical committee members (especially patients) had strong views that patients differ in their priorities and values, that they rank different outcomes differently, and should be allowed to make the decision themselves. They concluded that people should be presented with a fair and balanced summary of all the differences between the two procedures, and both services should be available to them. It was recognised that this may require service reconfiguration in some regions and changes to referral pathways, but this was trumped by ensuring patients had access to both treatments and were able to make a judgement themselves.

Patella resurfacing during total knee replacement: The committee considered three possibilities: No resurfacing; selective resurfacing; and routine resurfacing. There was extensive evidence comparing no resurfacing to routine resurfacing, demonstrating no difference in patient reported outcomes, but a higher rates of secondary patellar resurfacing in the non-resurfacing group. Patellar fracture was rare in the evidence reviewed. Although the economics favoured resurfacing, with a large potential saving across the NHS, the primary reason for the decision to offer patella resurfacing was that patients were clear that a secondary resurfacing was not an inconvenience but a major event associated with pain and risk. Patients preferred resurfacing at the time of TKR to prevent this risk. There was insufficient data on selective resurfacing and a research recommendation was made on this.

For shoulder surgeons and trusts providing shoulder replacements

Pre-operative rehabilitation: The value of pre operative rehabilitation for hips and knees was not replicated in the shoulder evidence review. A research recommendation was made to determine if preoperative rehabilitation would be beneficial.

Anaesthesia: Prior to surgery, options for anaesthesia (general and regional) and analgesia (local infiltration and nerve blocks) should be discussed with patients. General or regional anaesthesia combined with local infiltration demonstrated some benefit to patients. However, with continued advancements in day case shoulder replacements, the optimal combination of anaesthesia and analgesia to enhance the recovery pathway remains unclear.

Tranexamic acid: Economic modelling was carried out for the use of tranexamic acid (TXA) to prevent blood loss and reduce transfusion events. This cost effective intervention should be administered intravenously at induction of anaesthesia. Surgeons should also consider intra-articular or topical administration of TXA prior to wound closure. This mode of delivery was extrapolated from the hip and knee evidence but the committee agreed it should also apply to shoulder replacements as a safe and inexpensive intervention.

Shoulder replacement for osteoarthritis (OA): NICE recommends a conventional total shoulder replacement (TSR) for patients with an intact rotator cuff and adequate glenoid bone stock. It is important to highlight there is a lack of evidence in patients under the age of 60, and for the use of a reverse TSR to treat this condition. As such, two research recommendations were made to compare conventional TSR to reverse TSR; and to compare conventional TSR to humeral hemiarthroplasty in patients under the age of 60.

Shoulder replacement after previous proximal humeral fracture: With no high- quality evidence available, a research recommendation was made to look at the long-term outcomes for shoulder replacements after previous proximal humeral fracture (not acute trauma).

Research recommendations

NICE guidelines take considerable resources to produce. Despite the sheer prevalence of joint replacement surgery and the acknowledgement from patients of its life changing impact, the multiple systematic reviews in this guideline indicate an ongoing lack of high-quality evidence around a number of topics. As such the committee needed to make many research recommendations to produce evidence in these areas of uncertainty.

Conclusion

This article is aimed at providing you with a summary of the process and content of the new NICE guidelines on hip, knee and shoulder replacement, and how they might impact your surgical practice. The full guideline can be accessed at: www.nice.org.uk/guidance/ng157 and we would encourage surgeons conducting these procedures to read these carefully. Finally based on our experiences we would encourage BOA members to put themselves forward for future NICE guideline committees.