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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. Results. OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. Conclusion. These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383–92


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


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 152 - 152
1 Sep 2012
Van Der Weegen W Hoekstra H Sybesma T Bos E Schemitsch E Poolman R
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Background. Hip resurfacing arthroplasty (HRA) has seen a recent revival with third generation Metal-on-Metal prostheses and is now widely in use. However, safety and effectiveness of hip resurfacing are still questioned. We systematically reviewed peer-reviewed literature on hip resurfacing arthroplasty to address these issues. Objective. To evaluate implant survival and functional outcomes of hybrid Metal-on-Metal hip resurfacing arthroplasty (HRA). Method. Electronic databases and reference lists were searched from 1988 to May 2010. Identified abstracts were checked for inclusion or exclusion by two independent reviewers. Data were extracted and summarized by one reviewer and verified by a second reviewer. Main study endpoint was implant survival, which we compared with the National Institute of Clinical Excellence (NICE) benchmark. We also evaluated radiological and functional outcomes, failure modes and other adverse events. The quality of evidence was judged using the Grading of Recommendations Assessment, Development and Evaluation system (GRADE). Results. We identified 539 articles, of which 29 met the inclusion criteria. The studies included one randomised clinical trial, 27 prospective case series and one retrospective case series. Data were extracted from these 29 articles, totalling 10621 resurfaced hips, providing details on five out of 11 resurfacing devices on the market. Mean follow up ranged from 0.6 to 10.5 years and implant survival ranged from 84% to 100%. Of the 10621 hips, 370 were revised (3.5%), with aseptic loosening as most frequent failure mode. None of the HRA implants used to date met the full 10 year NICE benchmark. Thirteen studies showed satisfactory implant survival percentages compared to the three year NICE entry-benchmark. These 13 studies used the BHR implant (eight studies), the Conserve plus (two studies), the Durom implant (one study), the Cormet 2000 implant (one study) or both the McMinn and the BHR implant (one study)


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 502 - 502
1 Sep 2012
Renkawitz T Koller M Bonnlaender G Drescher J Riederer T Grifka J Schaumburger J Lechler P
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Background. For some time, optimized perioperative pathway protocols have been implemented in orthopedic surgery. In our hospital an accelerated clinical pathway has been successfully in effect for several years, focused on safely decreasing patients' length of stay and increasing their function at the time of discharge. The aim of the present project was to evaluate whether a further optimization is even more promising regarding early postoperative outcome parameters. Materials and Methods. Prospective, parallel group design in an Orthopaedic University Medical Centre. 143 patients, scheduled for unilateral primary total knee replacement (TKR) under perioperative regional analgesia were included. 76 patients received a Standard Accelerated Clinical Pathway (SACP). 67 patients received an Optimized Accelerated Clinical Pathway (OACP) including patient-controlled regional analgesia pumps, ultra-early/doubled physiotherapy and motor driven continuous passive motion machine units. Main measures were early postoperative pain on a visual analogue scale, consumption of regional anaesthetics, knee range of motion, time out of bed, walking distance/stair climbing, circumference measurements and Knee Society Scores of the operated leg. Patients in both groups were checked for a possible discharge by a blinded orthopedic surgeon on the 5th and 8th postoperative (po) day, using a discharge checklist including the KATZ Index of Independence in Activities of Daily Living, standard requirements for pain at rest/mobilization, walking distance and regular wound healing. A potential discharge was only approved if the patient was able to meet all six criteria from the discharge checklist. Re-admission within 6 weeks after discharge from hospital was registered. Results. Patients within the OACP had significant benefits regarding stair climbing/walking distance/time-out-of bed/circumference measurements of the thigh/Knee Society function score on the 5th po day and stair climbing/circumference measurements of the thigh on the 8th po day, and reduction of the consumption of regional anaesthetics. No significant reduction in length of stay was observed. Discussion. Early postoperative functional process indicators tended to be higher within the OACP group, but the main effects flatten in the course of the first eight postoperative days. Further, prospective randomised clinical trials with uniform, objective discharge criteria are needed


The Bone & Joint Journal
Vol. 97-B, Issue 6 | Pages 836 - 841
1 Jun 2015
Jónsson BY Mjöberg B

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: Bone Joint J 2015; 97-B:836–41


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 9 | Pages 1214 - 1221
1 Sep 2008
Egol K Walsh M Tejwani N McLaurin T Wynn C Paksima N

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 2 | Pages 245 - 250
1 Feb 2011
Wilson J Bajwa A Kamath V Rangan A

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 t-tests compared overall compression and compression at the articular side of the fracture.

The mean compression for plating was 819 N (sd 602, 95% confidence interval (CI)) and for tension band wiring was 77 N (sd 19, 95% CI) (p = 0.039). The mean compression on the articular side of the fracture for plating was 343 N (sd 276, 95% CI) and for tension band wiring was 1 N (sd 2, 95% CI) (p = 0.038).

During simulated movements, the mean compression was reduced in both groups, with tension band wiring at −14 N (sd 7) and for plating −173 N (sd 32). No increase in compression on the articular side was detected in the tension band wiring group.

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.


Bone & Joint Research
Vol. 2, Issue 10 | Pages 206 - 209
1 Oct 2013
Griffin XL McArthur J Achten J Parsons N Costa ML

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: Bone Joint Res 2013;2:206–9.


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 6 | Pages 829 - 836
1 Jun 2005
Kreder HJ Hanel DP Agel J McKee M Schemitsch EH Trumble TE Stephen D

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.