Towards phase III, multi-centred RCTs of functional outcome of TKA using flexible electro-goniometry : the challenge for the next decade

Rowe, P.J. (2009) Towards phase III, multi-centred RCTs of functional outcome of TKA using flexible electro-goniometry : the challenge for the next decade. In: IMechE conference on Knee Arthroplasty, 2009-04-30 - 2009-05-02.

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Total Knee Arthroplasty (TKA) has been standard clinical practice for 25 years. During this time it has been extensively researched both biomechanically and in terms of its clinical performance as an implant (survival, compatibility, wear, complications etc). This research, which was often funded by the relevant commercial implant company as part of the post market surveillance, has extended the scope and longevity of TKA but has failed to distinguish those implants, surgical and rehabilitation techniques which are most successful at restoring patient function. Over the last 20 years we have conducted a series of RCT's using flexible electro-goniometry to record the dynamic performance of the knee during a range of activities of daily living and a general quality of life score (SF36). Studies reported include outcome of mobile bearing TKA, with and without patella resurfacing, Standard versus High flexion TKA and individual effects. The most striking features of these data are that while producing a greater pain free range of passive motion the dynamic function of TKA patients remains significantly limited to up to 7 years post operation, loss of dynamic function associated with reduced activity levels and reduced quality of life and those with well preserved passive ROM preoperatively lose ROM and dynamic function post operatively. In general patients operate at about 70% of an equivalent age matched normal subject. While TKA patients clearly gain from operation we consider it unacceptable to leave them with these associated long term health risks. To maximise the patient's functional ability post TKA we need to identify which implants, surgical techniques and rehabilitation programmes lead to the best functional outcomes and in which patients. The established gold standard for such questions is a phase III, multi centre, randomised, controlled or comparative clinical trial. Such trials are designed to be statistically powerful and generalisable but often use clinical questionnaire as the outcome measures which due to their lack of sensitivity to dynamic functional performance of the knee fail to distinguish between patient groups in TKA. Flexible electrogoniometry presents a sensitive and relatively inexpensive alternative which, with suitable training, can be implemented be a research nurse of physiotherapist in a standard out-patient clinic. Currently the surgeon, therapist and patient are faced with a vast array of surgical, operative and rehabilitation options. The challenge for us as a research community over the next decade is to provide them with suitable comparative evidence of functional outcome to help guide choice. To this end we in Glasgow have formed a Functional Outcomes in Knee Arthroplasty Clinical Trials Collaboration involving The Bioengineering Unit of University of Strathclyde, The Clinical Trials Unit and Robertson Institute of Bio-statistics of Glasgow University, The School of Health and Social Care, Glasgow Caledonian University, The HealthQWest Research Consortium, The Glasgow and Clyde NHS and the Glasgow Clinical Research Facility. We intend to carry-out our own phase II and II trials and to adopt other Phase III trials. We would encourage others at this meeting to do the same and for us collectively to establish a Functional Outcome in Knee Arthroplasty Trials Network.