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The Bone & Joint Journal
Vol. 98-B, Issue 2 | Pages 152 - 159
1 Feb 2016
Corbacho B Duarte A Keding A Handoll H Chuang LH Torgerson D Brealey S Jefferson L Hewitt C Rangan A

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.

Methods

A cost utility analysis from the NHS perspective was performed. Differences between surgical and non-surgical treatment groups in costs and quality adjusted life years (QALYs) at two years were used to derive an estimate of the cost effectiveness of surgery using regression methods.


The Journal of Bone & Joint Surgery British Volume
Vol. 69-B, Issue 4 | Pages 643 - 646
1 Aug 1987
Kristiansen B Kofoed H

A new technique for the treatment of displaced fractures of the proximal humerus is described. Twelve fractures in 11 patients were managed by transcutaneous reduction using a Steinmann pin, and external fixation with a Hoffmann-type neutralising bar connected to two half-pins in the humeral head and three half-pins in the shaft. The pins were removed after four weeks. Two patients sustained redisplacement after a further injury, but in the others reduction was maintained. Two cases of pin-track infection resolved after antibiotics, but delayed union resulted. There were no neurovascular injuries and at follow-up of 6 to 12 months no refractures had been seen. The early functional results were excellent or satisfactory in nine cases


The Journal of Bone & Joint Surgery British Volume
Vol. 70-B, Issue 5 | Pages 821 - 824
1 Nov 1988
Kristiansen B Kofoed H

A consecutive series of 31 displaced fractures of the proximal humerus were randomly selected for treatment either by closed manipulation or by transcutaneous reduction and external fixation. Follow-up assessed the quality of reduction and healing as well as the functional outcome. The external fixation method gave better reduction, safer healing and superior function


The Bone & Joint Journal
Vol. 99-B, Issue 3 | Pages 383 - 392
1 Mar 2017
Handoll HH Keding A Corbacho B Brealey SD Hewitt C Rangan A

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.

Patients and Methods

Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied.


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 8 | Pages 1107 - 1112
1 Nov 2000
Hintermann B Trouillier HH Schäfer D

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


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. 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


Bone & Joint 360
Vol. 12, Issue 3 | Pages 27 - 30
1 Jun 2023

The June 2023 Shoulder & Elbow Roundup360 looks at: Proximal humerus fractures: what does the literature say now?; Infection risk of steroid injections and subsequent reverse shoulder arthroplasty; Surgical versus non-surgical management of humeral shaft fractures; Core outcome set needed for elbow arthroplasty; Minimally invasive approaches to locating radial nerve in the posterior humeral approach; Predictors of bone loss in anterior glenohumeral instability; Does the addition of motor control or strengthening exercises improve rotator cuff-related shoulder pain?; Terminology and diagnostic criteria used in patients with subacromial pain syndrome.


Bone & Joint Open
Vol. 4, Issue 2 | Pages 96 - 103
14 Feb 2023
Knowlson CN Brealey S Keding A Torgerson D Rangan A

Aims

Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this.

Methods

Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 2 | Pages 295 - 298
1 Mar 1991
Jakob R Miniaci A Anson P Jaberg H Osterwalder A Ganz R

There is a specific type of displaced four-part fracture of the proximal humerus which consists of valgus impaction of the head fragment; this deserves special consideration because the rate of avascular necrosis is lower than that of other displaced four-part fractures. Using either closed reduction or limited open reduction and minimal internal fixation, 74% satisfactory results can be achieved in this injury


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 3 | Pages 412 - 417
1 May 1997
Zyto K Ahrengart L Sperber A Törnkvist H

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


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 33 - 41
1 Jan 2020
Norman JG Brealey S Keding A Torgerson D Rangan A

Aims

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

Methods

A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot.


Bone & Joint Research
Vol. 5, Issue 10 | Pages 470 - 480
1 Oct 2016
Sabharwal S Patel NK Griffiths D Athanasiou T Gupte CM Reilly P

Objectives

The objective of this study was to perform a meta-analysis of all randomised controlled trials (RCTs) comparing surgical and non-surgical management of fractures of the proximal humerus, and to determine whether further analyses based on complexity of fracture, or the type of surgical intervention, produced disparate findings on patient outcomes.

Methods

A systematic review of the literature was performed identifying all RCTs that compared surgical and non-surgical management of fractures of the proximal humerus. Meta-analysis of clinical outcomes was performed where possible. Subgroup analysis based on the type of fracture, and a sensitivity analysis based on the type of surgical intervention, were also performed.


Bone & Joint Research
Vol. 6, Issue 10 | Pages 590 - 599
1 Oct 2017
Jefferson L Brealey S Handoll H Keding A Kottam L Sbizzera I Rangan A

Objectives

To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice.

Methods

A questionnaire was piloted with six orthopaedic surgeons using a ‘think aloud’ process. The final questionnaire contained 29 items and was distributed online to surgeon members of the British Orthopaedic Association and British Elbow and Shoulder Society. Descriptive statistics summarised the sample characteristics and fracture treatment of respondents overall, and grouped them by whether they changed practice based on PROFHER trial findings. Free-text responses were analysed qualitatively for emerging themes using Framework Analysis principles.


Bone & Joint Research
Vol. 5, Issue 5 | Pages 178 - 184
1 May 2016
Dean BJF Jones LD Palmer AJR Macnair RD Brewer PE Jayadev C Wheelton AN Ball DEJ Nandra RS Aujla RS Sykes AE Carr AJ

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.

Methods

A total of ten consecutive patients undergoing surgery for the treatment of a proximal humeral fracture from each of 11 United Kingdom hospitals were retrospectively identified over a 15 month period between January 2014 and March 2015. Data gathered for the 110 patients included patient demographics, injury characteristics, mode of surgical fixation, the grade of operating surgeon and the cost of the surgical implants.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 6 | Pages 799 - 804
1 Jun 2012
Hems TEJ Mahmood F

We reviewed 101 patients with injuries of the terminal branches of the infraclavicular brachial plexus sustained between 1997 and 2009. Four patterns of injury were identified: 1) anterior glenohumeral dislocation (n = 55), in which the axillary and ulnar nerves were most commonly injured, but the axillary nerve was ruptured in only two patients (3.6%); 2) axillary nerve injury, with or without injury to other nerves, in the absence of dislocation of the shoulder (n = 20): these had a similar pattern of nerve involvement to those with a known dislocation, but the axillary nerve was ruptured in 14 patients (70%); 3) displaced proximal humeral fracture (n = 15), in which nerve injury resulted from medial displacement of the humeral shaft: the fracture was surgically reduced in 13 patients; and 4) hyperextension of the arm (n = 11): these were characterised by disruption of the musculocutaneous nerve. There was variable involvement of the median and radial nerves with the ulnar nerve being least affected.

Surgical intervention is not needed in most cases of infraclavicular injury associated with dislocation of the shoulder. Early exploration of the nerves should be considered in patients with an axillary nerve palsy without dislocation of the shoulder and for musculocutaneous nerve palsy with median and/or radial nerve palsy. Urgent operation is needed in cases of nerve injury resulting from fracture of the humeral neck to relieve pressure on nerves.


Bone & Joint 360
Vol. 1, Issue 2 | Pages 21 - 23
1 Apr 2012

The April 2012 Shoulder & Elbow Roundup360 looks at katakori in Japan, frozen shoulder, if shoulder impingement actually exists, shoulder arthroscopy and suprascapular nerve blocks, why shoulder replacements fail, the infected elbow replacement, the four-part fracture, the acromion index, and arm transplantation


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 6 | Pages 720 - 721
1 Jun 2011
Rangan A Maffulli N

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 12 | Pages 1602 - 1607
1 Dec 2008
Bogner R Hübner C Matis N Auffarth A Lederer S Resch H

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 1 | Pages 1 - 11
1 Jan 2011
Murray IR Amin AK White TO Robinson CM

Most proximal humeral fractures are stable injuries of the ageing population, and can be successfully treated non-operatively. The management of the smaller number of more complex displaced fractures is more controversial and new fixation techniques have greatly increased the range of fractures that may benefit from surgery.

This article explores current concepts in the classification and clinical aspects of these injuries, reviewing the indications, innovations and outcomes for the most common methods of treatment.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1335 - 1340
1 Oct 2009
Kontakis GM Tosounidis TI Christoforakis Z Hadjipavlou AG

We reviewed the outcome of 28 patients who had been treated using the Aequalis fracture prosthesis for an acute fracture of the proximal humerus at a mean follow-up of 39.3 months (24 to 63). The mean age of the patients at the time of the fracture was 66.3 years (38 to 80). The mean Constant score was 68.2 (37 to 84) for the operated shoulder, which represented 89.5% of the mean score for the uninjured side (p < 0.001). The quality of the reconstruction as shown on the immediate post-operative radiographs was categorised into three types, anatomical, acceptable, and unacceptable, depending on the position of the tuberosities relative to the prosthetic head and the humeral shaft. Anatomical reconstruction was associated with a higher mean Constant score as well as higher mean values of anterior forward elevation, abduction and external rotation than the other types, but the differences were not statistically significant (p > 0.231).

A total of 18 patients had active anterior elevation ≥150°. Their mean active abduction and external rotation were 163.6° and 31.3°, respectively. In seven of the 28 patients, the mean active anterior elevation, abduction and external rotation were 130.7°, 129.2° and 22.8°, respectively. In all, 12 patients were very satisfied with the results, 12 were satisfied, two were dissatisfied and two were disappointed; 26 reported no or only mild pain while only two had moderate pain. In five patients proximal migration of the humeral head was shown on the anteroposterior radiographs of the shoulder. No evidence of loosening was found in any prosthesis.