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. Results. Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions. A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1

The aim of this study was to quantify the stability of fracture-implant complex in fractures after fixation. A total of 15 patients with an undisplaced fracture of the femoral neck, treated with either a dynamic hip screw or three cannulated hip screws, and 16 patients with an AO31-A2 trochanteric fracture treated with a dynamic hip screw or a Gamma Nail, were included. Radiostereometric analysis was used at six weeks, four months and 12 months post-operatively to evaluate shortening and rotation.

Migration could be assessed in ten patients with a fracture of the femoral neck and seven with a trochanteric fracture. By four months post-operatively, a mean shortening of 5.4 mm (-0.04 to 16.1) had occurred in the fracture of the femoral neck group and 5.0 mm (-0.13 to 12.9) in the trochanteric fracture group. A wide range of rotation occurred in both types of fracture. Right-sided trochanteric fractures seem more rotationally stable than left-sided fractures.

This prospective study shows that migration at the fracture site occurs continuously during the first four post-operative months, after which stabilisation occurs. This information may allow the early recognition of patients at risk of failure of fixation.

Cite this article: Bone Joint J 2015;97-B:391–7.