Title: Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement: A randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Background Total knee replacement (TKR) is a common operation performed to provide pain relief and restore functional ability. In 2012, 76,051 primary TKRs were performed in the NHS, with osteoarthritis (OA) being the primary indication (97% of cases) [2]. Inpatient physiotherapy is routinely provided after TKR to enhance recovery prior to discharge. However, our work has identified national variation in the provision of physiotherapy after discharge [3]. While there is evidence that post-discharge physiotherapy can improve functional outcomes up to 3-months post-operative, the longer-term benefits are unknown [4]. Physiotherapy should address patient expectations [5]; after TKR these mainly relate to long-term functional and pain outcomes [6,7]. Therefore, further research is needed to establish if post-discharge physiotherapy can help patients gain a better long-term functional outcome after TKR. As part of a NIHR Programme Grant for Applied Research (RP-PG-0407-10070) we have developed a novel outpatient group-based physiotherapy intervention following TKR and conducted a feasibility study for a randomised control trial (RCT) of the intervention, including 6-month follow-up. This work demonstrated that the definitive trial is feasible and the intervention is acceptable to patients, alongside providing data to inform a sample size calculation. We would now like to conduct the definitive RCT. Aims The aim of this RCT is to evaluate the long-term clinical effectiveness and cost-effectiveness of a six week group-based outpatient physiotherapy intervention following TKR in addition to usual care. Plan of investigation 256 patients listed for TKR will be recruited over a 14-month period from two high-volume orthopaedic centres in Bristol: a NHS regional orthopaedic centre and a NHS treatment centre. Patients will be randomised through the Bristol Clinical Trials and Evaluation Unit. Patients allocated to the usual care group will be offered all services provided as standard practice in their centre. This involves a booklet about exercise and referral for outpatient physiotherapy on a needs only basis. Patients in the intervention group will receive the same usual care and in addition be invited to attend an outpatient physiotherapy class hosted by the regional centre. Beginning six weeks after surgery, the intervention will involve task-orientated and individualised exercises delivered in a group-based setting over six weeks. The intervention will use a group-based setting because this has been found to be a cost-effective method of delivering physiotherapy without comprising effectiveness for patients with knee OA [8]. The intervention will take a patient-centred approach through a combined focus on task-orientated exercises and individualised physiotherapy treatment, with the aim of improving ability to participate in valued activities. Assessment will be by questionnaire prior to surgery and 3-months, 6-months, and 12-months after surgery to collect clinical outcomes and resource use data. The primary outcome will be the Lower Extremity Functional Scale [9] at 12-months post-operative. Secondary outcomes include: knee pain, symptoms, quality of life, activity level, psychological status and self-efficacy for rehabilitation. The primary economic result will estimate the incremental cost per quality adjusted life year (QALY) gained from delivering this intervention from an NHS and personal social services perspective. Secondary economic outcomes will estimate cost-effectiveness in relation to the primary outcome. Potential benefits to patients and NHS This research will be of direct benefit to patients and the NHS by providing evidence on the long-term effectiveness and cost-effectiveness of outpatient physiotherapy after TKR. The classes are offered on a rolling weekly basis, with patients joining the group as and when needing, which is highly attractive for hospital administration of staff and room requirements. If the intervention is found to be effective and cost-effective, implementation into clinical practice could lead to improvement in patients outcomes after TKR and improved NHS resource efficiency.

Lay abstract: Knee replacement is a common operation for patients with osteoarthritis. It is a major operation with a long recovery period. Physiotherapy is an important part of the recovery process because it can help improve strength and movement in the replaced knee and allow people to gain the maximum benefit from the operation. However, not all hospitals offer physiotherapy to patients once they have been discharged from hospital after their knee replacement operation. We plan to find out whether it is helpful to offer exercise classes to patients following knee replacement. We have already conducted a small version of the study so we know that patients are willing to take part in the study and attend the exercise classes. 256 patients from two hospitals in Bristol will take part in the study. Half of people will be chosen at random to receive usual care where they are referred to outpatient physiotherapy on a needs only basis i.e. if they have poor mobility. The other half will be invited to attend an exercise class, in addition to receiving usual care . This class will be every week for six weeks, starting at six weeks after knee replacement surgery. In the class, patients will practice task-related exercises such as walking, stair climbing, and kneeling. They will also have individual treatment during the group that may consist of exercises or hands-on treatment. We will then ask everyone in the study to complete questionnaires during the first year after surgery to see if the exercise classes improve patients mobility. We will also collect information to compare the cost of providing both treatments. The findings from this study will help us to know if outpatient physiotherapy can improve patient s mobility up to one-year after knee replacement surgery and is good value for money to invest NHS resources.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL