Academic journal article Applied Health Economics and Health Policy

EXOGEN Ultrasound Bone Healing System for Long Bone Fractures with Non-Union or Delayed Healing: A NICE Medical Technology Guidance

Academic journal article Applied Health Economics and Health Policy

EXOGEN Ultrasound Bone Healing System for Long Bone Fractures with Non-Union or Delayed Healing: A NICE Medical Technology Guidance

Article excerpt

Published online: 25 July 2014

© The Author(s) 2014. This article is published with open access at Springerlink.com

Abstract A routine part of the process for developing National Institute for Health and Care Excellence (NICE) medical technologies guidance is a submission of clinical and economic evidence by the technology manufacturer. The Birmingham and Brunel Consortium External Assessment Centre (EAC; a consortium of the University of Birmingham and Brunel University) independently appraised the submission on the EXOGEN bone healing system for long bone fractures with non-union or delayed healing. This article is an overview of the original evidence submitted, the EAC's findings, and the final NICE guidance issued.

1 Introduction

This article presents a summary of the External Assessment Centre (EAC) report commissioned by the National Institute for Health and Care Excellence (NICE) for the EXOGEN ultrasound bone healing system for long bone fractures with nonunion or delayed healing. It is part of a series of NICEMedical Technology Guidance summaries being published in Applied Health Economics and Health Policy under the remit ofNICE's Medical Technology Evaluation Programme (MTEP) [1-4].

2 The Decision Problem

2.1 Disease Overview

This guidance relates to long bone fractures with non-union or delayed healing. For the purpose of this evaluation, long bones were defined as the humerus, ulna, radius, femur, tibia and fibula. The time that it takes for a fracture to heal varies from patient to patient. 'Delayed union' is said to occur when there is no radiological evidence of healing within 3 months of fracture. 'Non-union' is established when 9 months have elapsed since the original fracture, with no visible signs of healing in the past 3 months. Delay in fracture healing reduces patients' quality of life and general well-being. Treatment may be long and complex, resulting in high costs for the NHS. Donaldson et al. [5] used data from the Health Survey for England 2002-2004 to estimate the incidence of long bone fractures at 1.2 and 0.8 per 100 person-years for men and women respectively, about 5-10 % of which will not heal as expected [6].

2.2 Current Treatment Options

Patients are usually treated immediately after fracture, with open or closed reduction (realignment of the bone ends). The limb is immobilised using a plaster or splint, and possibly with insertion of internal or external fixings. X-rays are used to verify alignment of the bone and to assess progress towards healing through bridging of the gap between the fractured bone ends with new bone cortex. Patients not showing progression to healing by 3 months (delayed union) do not usually receive further surgery at this stage unless they have particular indications, such as an unstable or misaligned fracture or a large inter-fragment gap. Surgery may take place between 3 and 9 months after fracture, but clinical practice varies and decisions about the timing of surgery are made on an individual patient basis. If the bone fails to heal by 9 months after the original injury (non-union), surgery will usually be required. Surgery for delayed or non-union usually involves internal or external fixation and bone grafting (with harvesting from the patient's iliac crest).

2.3 EXOGEN Ultrasound Bone Healing System: Device

The EXOGEN ultrasound bone healing system (referred to hereafter as EXOGEN) is manufactured by Smith and Nephew. It delivers low-intensity pulsed ultrasound waves, and is licensed for healing non-union fractures and accelerating the healing of fresh fractures [7]. It is claimed to promote bone healing by stimulating the removal of old bone, increasing the production of new bone and increasing the rate at which fibrous matrix at a fracture site is converted to mineralised bone. Successful use of EXOGEN may eliminate the need for surgery and its associated complications. Quicker healing may also have a positive impact on a patient's quality of life and functional capacity. …

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