Aims. The PROximal Fracture of the Humerus Evaluation by Randomisation
(PROFHER)
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
A total of 20 patients with a depressed fracture
of the lateral tibial plateau (Schatzker II or III) who would undergo open
reduction and internal fixation were randomised to have the metaphyseal
void in the bone filled with either porous titanium granules or
autograft bone. Radiographs were undertaken within one week, after
six weeks, three months, six months, and after 12 months. The primary outcome measure was recurrent depression of the joint
surface: a secondary outcome was the duration of surgery. The risk of recurrent depression of the joint surface was lower
(p <
0.001) and the operating time less (p <
0.002) when titanium
granules were used. The indication is that it is therefore beneficial to use porous
titanium granules than autograft bone to fill the void created by
reducing a depressed fracture of the lateral tibial plateau. There
is no donor site morbidity, the operating time is shorter and the
risk of recurrent depression of the articular surface is less. Cite this article:
We performed a prospective, randomised trial to evaluate the outcome after surgery of displaced, unstable fractures of the distal radius. A total of 280 consecutive patients were enrolled in a prospective database and 88 identified who met the inclusion criteria for surgery. They were randomised to receive either bridging external fixation with supplementary Kirschner-wire fixation or volar-locked plating with screws. Both groups were similar in terms of age, gender, hand dominance, fracture pattern, socio-economic status and medical co-morbidities. Although the patients treated by volar plating had a statistically significant early improvement in the range of movement of the wrist, this advantage diminished with time and in absolute terms the difference in range of movement was clinically unimportant. Radiologically, there were no clinically significant differences in the reductions, although more patients with AO/OTA (Orthopaedic Trauma Association) type C fractures were allocated to the external fixation group. The function at one year was similar in the two groups. No clear advantage could be demonstrated with either treatment but fewer re-operations were required in the external fixation group.
Compression and absolute stability are important in the management of intra-articular fractures. We compared tension band wiring with plate fixation for the treatment of fractures of the olecranon by measuring compression within the fracture. Identical transverse fractures were created in models of the ulna. Tension band wires were applied to ten fractures and ten were fixed with Acumed plates. Compression was measured using a Tekscan force transducer within the fracture gap. Dynamic testing was carried out by reproducing cyclical contraction of the triceps of 20 N and of the brachialis of 10 N. Both methods were tested on each sample. Paired The mean compression for plating was 819 N ( During simulated movements, the mean compression was reduced in both groups, with tension band wiring at −14 N ( Pre-contoured plates provide significantly greater compression than tension bands in the treatment of transverse fractures of the olecranon, both over the whole fracture and specifically at the articular side of the fracture. In tension band wiring the overall compression was reduced and articular compression remained negligible during simulated contraction of the triceps, challenging the tension band principle.
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. Controversy exists regarding
the optimal treatment for patients with unstable trochanteric proximal
femoral fractures. The recognised treatment alternatives are extramedullary
fixation usually with a sliding hip screw and intramedullary fixation
with a cephalomedullary nail. Current evidence suggests that best
results and lowest complication rates occur using a sliding hip screw.
Complications in these difficult fractures are relatively common
regardless of type of treatment. We believe that a novel device,
the X-Bolt dynamic plating system, may offer superior fixation over
a sliding hip screw with lower reoperation risk and better function.
We therefore propose to investigate the clinical effectiveness of
the X-bolt dynamic plating system compared with standard sliding
hip screw fixation within the framework of a the larger WHiTE (Warwick
Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article:
A total of 179 adult patients with displaced intra-articular fractures of the distal radius was randomised to receive indirect percutaneous reduction and external fixation (n = 88) or open reduction and internal fixation (n = 91). Patients were followed up for two years. During the first year the upper limb musculoskeletal function assessment score, the SF-36 bodily pain sub-scale score, the overall Jebsen score, pinch strength and grip strength improved significantly in all patients. There was no statistically significant difference in the radiological restoration of anatomical features or the range of movement between the groups. During the period of two years, patients who underwent indirect reduction and percutaneous fixation had a more rapid return of function and a better functional outcome than those who underwent open reduction and internal fixation, provided that the intra-articular step and gap deformity were minimised.