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4 Committee discussion

Clinical-effectiveness overview

Pain, function and stiffness

4.1 The clinical evidence shows that AposHealth improves pain, function and stiffness, but there are some uncertainties. The committee noted that the authors of the randomised controlled trial (RCT) publication said there was uncertainty in whether the improvements were clinically important. But the committee was reassured by the clinical and patient expert advisers reporting very positive outcomes. A patient expert adviser said that they continue to use the technology effectively as pain relief. The committee acknowledged that the rest of the evidence base is limited in methodological quality, but the outcomes reported across the evidence base are consistent. The committee concluded that AposHealth may lead to improvements in pain, function and stiffness for people with knee osteoarthritis.

Knee replacement surgery

4.2 AposHealth may delay total knee replacement surgery, but it is uncertain for how long. The EAG reported that 2 non-comparative studies based in the US and UK included the rate of total knee replacement as a primary outcome. Drew (2022) and Greene (2022) reported an 86% and 84% rate of total knee replacement avoidance for people using AposHealth at 2 years. The clinical and patient expert advisers agreed that these rates reflected their experience of using the technology in the NHS for up to 7 years. The committee noted that the clinical evidence was non-comparative but acknowledged the support from clinical and patient expert advisers.

NHS considerations

Patient selection

4.3 People referred for AposHealth should meet the referral criteria for total knee replacement surgery. The committee discussed patient selection and the position of AposHealth in the care pathway. The committee noted that the clinical evidence doesn't specify a clear place or patient population for AposHealth in the care pathway. Clinical expert advisers using the technology stated that AposHealth is usually delivered as part of the musculoskeletal secondary care service. People must have tried other non-surgical standard care and have met the referral criteria for a total knee replacement consultation. Clinical expert advisers also explained that AposHealth may be contraindicated for people with balance issues and people with especially severe osteoporosis but noted that eligibility is reviewed on an individual basis. The committee acknowledged that the technology may not be suitable for certain people but accepted that healthcare professionals will use clinical judgement when referring people for AposHealth.

4.4 The decision to undergo knee surgery is a shared decision making process and there are multiple factors involved (see NICE's guidance on shared decision making). A patient expert adviser felt that surgery wasn't their preferred treatment option because of their young age and negative past experiences in their family. Clinical expert advisers agreed that a person's age, social and economic factors, comorbidities and understanding of the procedure, may all influence their decision to have surgery. The committee acknowledged that there are many reasons people may not want or cannot have surgery, and more strategies to manage symptoms for this group, such as AposHealth, are necessary.


4.5 AposHealth can provide immediate symptom relief, which may encourage adherence for people using it. Clinical expert advisers said that they rarely find people do not use AposHealth as recommended. People are advised to wear the technology at home or at work for short periods of time. A patient expert adviser said that wearing the technology at home was convenient, and that they are eager to wear the device because of an immediate relief in symptoms. Clinical expert advisers noted that the instant symptom relief experienced by people can lead to over-use which may result in muscle stiffness or soreness if not monitored appropriately. The committee noted that current users are selectively sampled and there is no data on adherence in a wider NHS setting but accepted that it is unlikely that people may not use AposHealth as recommended.

4.6 AposHealth needs continued use for ongoing benefits. Clinical experts stated that using the technology daily improves muscle activity around the joint, which can lead to benefits when not actively wearing the technology. After the initial programme, people are advised to use the technology 2 to 4 times a week to remain stable. A patient expert adviser confirmed that wearing the technology as instructed has enabled them to do more exercise outside of the treatment programme, and now only uses the technology in response to acute joint pain or stiffness. The committee acknowledged that the treatment may become less effective over time if use is stopped.

Other patient benefits or issues

4.7 AposHealth may benefit other lower limb joints. Clinical expert advisers noted that people with knee osteoarthritis often have comorbidities, such as back pain. Clinical expert advisers confirmed that they assess the impact of AposHealth on other lower limb joints during the initial AposHealth assessment to ensure the calibration of the technology is beneficial to all joints. The company noted that there is clinical evidence available for people with lower back and hip pain. This evidence was not presented to the committee or reviewed by the EAG, but the committee was reassured that use of AposHealth was unlikely to have adverse effects on other joints.

Decision modelling overview

4.8 There are uncertainties in the economic modelling because of limited data. The EAG reported that AposHealth was cost saving at 5 years but became cost incurring at 10 years. The committee accepted that the main cost savings come from a reduction in total knee replacement surgery. The committee noted that there is limited evidence for a reduction in total knee replacement beyond 2 years. But it acknowledged that clinical expert advisers who have up to 7 years of experience delivering the technology also support the plausibility of reductions in knee replacement surgery sustained over time. Clinical expert advisers also noted that AposHealth continues to be funded in their local area. The committee concluded that there are still uncertainties around the evidence for delaying total knee replacement surgery but accepted the potential cost savings for the technology up to 5 years.

4.9 The EAG's sensitivity analysis showed that the reduction in standard care costs when using AposHealth is one of the main drivers in the cost model. The EAG explained that the assumption of a 15% reduction in standard care costs comes from published clinical evidence showing reduced pain and increased function, and unpublished audit data from the US and UK suggesting a decrease in resource use. A patient expert adviser noted that they haven't needed further help from their local service and have used less medication since using the technology. The committee acknowledged that the clinical and patient expert adviser user experience is positive for reducing use of healthcare services

Further research

4.10 The committee suggested that real-world data could be collected to determine the clinical effectiveness and cost benefit of AposHealth over a longer time horizon. The committee noted that there is a high-quality RCT comparing AposHealth with a sham device and acknowledged that there are difficulties in designing comparative studies because of the uncertainties in the standard care pathway. The committee agreed that the collection of high-quality real-world data, with outcomes including standard care resource use, health-related quality of life, and long-term outcomes such as rates of total knee replacement may be appropriate. The committee recommended that data should continue to be collected for the wider population of people with knee osteoarthritis, as well as people who have met the referral criteria for a total knee replacement. It noted that health-related quality of life data may be collected using standardised patient reported outcome measures, such as the EQ-5D. The committee agreed that long-term data collection over 5 to 10 years will help to establish the cost benefits of AposHealth over a longer time horizon. The committee suggested that this data could be collected through a high-quality national registry (such as the National Joint Registry).