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The Bone & Joint Journal
Vol. 101-B, Issue 8 | Pages 995 - 1001
1 Aug 2019
Nicholson JA Clement N Goudie E Robinson CM

Aims

The primary aim of this study was to establish the cost-effectiveness of the early fixation of displaced midshaft clavicle fractures.

Patients and Methods

A cost analysis was conducted within a randomized controlled trial comparing conservative management (n = 92) versus early plate fixation (n = 86) of displaced midshaft clavicular fractures. The incremental cost-effectiveness ratio (ICER) was used to express the cost per quality-adjusted life-year (QALY). The Six-Dimension Short-Form Health Survey (SF-6D) score was used as the preference-based health index to calculate the cost per QALY at 12 months after the injury.


Bone & Joint Research
Vol. 5, Issue 10 | Pages 481 - 489
1 Oct 2016
Handoll HHG Brealey SD Jefferson L Keding A Brooksbank AJ Johnstone AJ Candal-Couto JJ Rangan A

Objectives

Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck.

Methods

The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons.