The clinical effectiveness of biological treatment adjuncts in the management of acute and un-united fractures

Abstract

BACKGROUND Fractures are common. The annual incidence of fresh fractures is estimated to be 3.6 per 100 people in England and Wales. Traditional management, employing nonoperative immobilisation strategies, has been replaced by a much more operative approach. The aim of this thesis is to understand and add to the evidence that supports available biological adjuncts to fracture management. EXPLORATION OF THE EVIDENCE THROUGH SYNTHESIS Several systematic reviews have been performed to review the currently available evidence for the clinical effectiveness of biological adjuncts. Adjuncts were chosen that are currently available for use in routine clinical practice. These reviews particularly focused on identifying where the evidence was of poor quality or did not exist to support such clinical applications. These reviews found that overall the quality and breadth of the evidence was limited. This was particularly true for the evidence to support the use of demineralised bone matrix and platelet-rich therapies. Ultrasound and electromagnetic induction were more established and few opportunities were identified to further test their effectiveness. DEVELOPMENT AND REPORTING OF A TEST OF CLINICAL EFFECTIVENESS The development of a protocol followed, which involved determining an appropriate experimental model in which to test one of the biological adjuncts. This protocol reflected a determination to test the clinical effectiveness, rather than efficacy, of platelet-rich plasma. The trial did not demonstrate a significant effect of platelet-rich plasma in the treatment of patients with an internally fixed intracapsular fracture of the proximal femur. The effect estimate included potentially important benefits or harms from the treatment. DISCUSSION This thesis summarises the diverse evidence available concerning biological adjuncts, proposes a protocol to test the clinical effectiveness of one, and tests this in a pragmatic controlled trial. The challenges, exemplified in the trial reported here, to the conduct of randomised trials of complex interventions in surgery are highlighted and approaches to overcome these obstacles discussed.

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