Defining the fracture population in a pragmatic multicentre randomised controlled trial : PROFHER and the Neer classification of proximal humeral fractures

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

Isolated patellofemoral osteoarthritis: A systematic review of treatment options using the GRADE approach

Background and purpose The optimal treatment for isolated patellofemoral osteoarthritis is unclear at present. We systematically reviewed the highest level of available evidence on the nonoperative and operative treatment of isolated patellofemoral osteoarthritis to develop an evidenced-based discussion of treatment options

Arthroscopically assisted anatomical coracoclavicular ligament reconstruction using tendon graft

We describe a method of arthroscopically assisted, mini-open, anatomical reconstruction of the coracoclavicular ligament. This method restores both components of the native ligament with the aim of achieving maximum stability with minimal disruption of the normal anatomy. Using the same principles of ligament reconstruction that are employed in other joints, transosseous tunnels are created following the native footprints of the conoid and trapezoid ligaments and an autologous graft is fixed using a PEEK screw. Adequate healing of the ligament occurs within the bone, to prevent stress risers with an appropriate working length. This procedure is unique, as it replaces the torn ligament with a natural substitute, in the appropriate location, through a minimally invasive procedure. This technique would be suitable for treatment of patients with either grade III or V acute acromioclavicular dislocations. Clinical outcomes for the first 13 consecutive patients treated with this procedure are reported, revealing excellent satisfaction rates with a Constant score of 96.6 at final follow-up