Aims

A pragmatic multicentre randomised controlled trial (PROFHER) was conducted in United Kingdom National Health Service (NHS) hospitals to evaluate the clinical effectiveness and cost effectiveness of surgery compared with non-surgical treatment for displaced fractures of the proximal humerus involving the surgical neck in adults.

Aims

The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up.

In 42 elderly patients, 33 women and nine men with a mean age of 72 years, we treated displaced fractures of the proximal humerus (34 three-part, 8 four-part) using a blade plate and a standard deltopectoral approach. Functional treatment was started immediately after surgery. We reviewed 41 patients at one year and 38 at final follow-up at 3.4 years (2.4 to 4.5). At the final review, all the fractures had healed. The clinical results were graded as excellent in 13 patients, good in 17, fair in seven, and poor in one. The median Constant score was 73 ± 18. Avascular necrosis of the humeral head occurred in two patients (5%). We conclude that rigid fixation of displaced fractures of the proximal humerus with a blade plate in the elderly patient provides sufficient primary stability to allow early functional treatment. The incidence of avascular necrosis and nonunion was low. Restoration of the anatomy and biomechanics may contribute to a good functional outcome when compared with alternative methods of fixation or conservative treatment. Regardless of the age of the patients, we advocate primary open reduction and rigid internal fixation of three- and four-part fractures of the proximal humerus

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

Introduction. There is considerable uncertainty about the optimal treatment of displaced four-part fractures of the proximal humerus. Within the last decade locking plate technology has been considered a breakthrough in the treatment of these complex injuries. Methods. We systematically identified and reviewed clinical studies of the benefits and harms after osteosynthesis with locking plates in displaced four-part fractures. Results. We included fourteen studies with 374 four-part fractures. There were no randomised trials, one prospective observational comparative study, three retrospective observational comparative studies, and ten case series. Small studies with a high risk of bias precluded reliable estimates of functional outcome. Unexpected high rates of complications (range 16% to 64%) and re-operations (range 11% to 27%) were reported. Conclusion. The empirical foundation for the clinical value of locking plates in displaced four-part fractures of the proximal humerus is very sketchy. We emphasise the need for well conducted randomised trials and observational studies

Introduction. A review of the literature showed a discrepancy between biomechanical and clinical studies on fracture fixation failure in patients with poor bone quality. The objective of the present study is to assess the influence of local bone status on complications after surgical treatment of proximal humerus fractures. Methods. A prospective cohort study was initiated in 2007. The inclusion criteria were closed displaced fractures of the proximal humerus, primary fracture treatment with a Philos plate, patients aged 50 to 90, normal pre-trauma function of both shoulders in accordance to age, and monotrauma. There was active follow-up for one year with radiological assessment at clinical centers from four countries. Bone quality at the proximal humerus was determined preoperatively for the contralateral side of the fracture by CT scan, and at the contralateral radius within six weeks post-surgery by DXA. The occurrence of complications was monitored up to one year post-surgery. Independent x-ray evaluation and final classification of all complications will be performed at the end by a study review board using anonymous data and x-rays. Preliminary Results. 157 patients, 127 female (79%) met the inclusion criteria. Their mean age at time of surgery is 69 (range 50–89). 119 patients (100%) attended the 1-year follow-up assessment, 64 (96%) the one at 3 months, and 148 (99%) the 6 week follow-up examination. According to the WHO criteria, 107 patients (71%) suffered from either osteopenia or osteoporosis, while 43 patients (29%) had a normal T-score. The overall reported complication rate was 39%. However, the number of intraoperative complications was 0.6%, bone/fracture complications 19.1%, implant complications 15.3%, and general complications 14.6%. Discussion. Fixation of proximal humerus fractures with Philos plates in elderly people with osteoporotic bone is associated with a high rate of fixation failure. Final results will be reported after x-rays, local BMD (CT- based) and complications assessment have been conducted

We randomised 40 elderly patients of mean age 74 years with displaced three- or four-part fractures of the humerus to either conservative treatment or tension-band osteosynthesis. At one year and after three to five years, clinical follow-up showed no functional differences between the two groups of patients, with optimal function achieved within one year. There were major complications only in the surgically-treated group. Radiological review showed that surgery had improved the position of the fractured humeral head, but this was not reflected in improved function. Semi-rigid fixation with tension-band wiring of displaced multifragment fractures of the proximal humerus in the elderly did not improve the functional outcome when compared with conservative treatment

Aims

The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures

Objectives

The PROximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial has recently demonstrated that surgery is non-superior to non-operative treatment in the management of displaced proximal humeral fractures. The objective of this study was to assess current surgical practice in the context of the PROFHER trial in terms of patient demographics, injury characteristics and the nature of the surgical treatment.

The surgical treatment of three- and four-part fractures of the proximal humerus in osteoporotic bone is difficult and there is no consensus as to which technique leads to the best outcome in elderly patients. Between 1998 and 2004 we treated 76 patients aged over 70 years with three- or four-part fractures by percutaneous reduction and internal fixation using the Humerusblock.

A displacement of the tuberosity of > 5 mm and an angulation of > 30° of the head fragment were the indications for surgery.

Of the patients 50 (51 fractures) were available for follow-up after a mean of 33.8 months (5.8 to 81). The absolute, age-related and side-related Constant scores were recorded. Of the 51 fractures, 46 (90.2%) healed primarily. Re-displacement of fragments or migration of Kirschner wires was seen in five cases. Necrosis of the humeral head developed in four patients. In three patients a secondary arthroplasty had to be performed, in two because of re-displacement and in one for necrosis of the head. There was one case of deep infection which required a further operation and one of delayed healing.

The mean Constant score of the patients with a three-part fracture was 61.2 points (35 to 87) which was 84.9% of the score for the non-injured arm. In four-part fractures it was 49.5 points (18 to 87) or 68.5% of the score for the non-injured arm.

The Humerusblock technique can provide a comfortable and mobile shoulder in elderly patients and is a satisfactory alternative to replacement and traditional techniques of internal fixation.