Aims. The aim of this prospective randomised controlled trial was to compare non-operative and operative management for acute isolated displaced fractures of the olecranon in patients aged ≥ 75 years. Patients and Methods. Patients were randomised to either non-operative management or operative management with either tension-band wiring or fixation with a plate. They were reviewed at six weeks, three and six months and one year after the injury. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year. Results. A total of 19 patients were randomised to non-operative (n = 8) or operative (n = 11; tension-band wiring (n = 9), plate (n = 2)) management. The trial was stopped prematurely as the rate of complications (nine out of 11, 81.8%) in the operative group was considered to be unacceptable. There was, however, no difference in the mean DASH scores between the groups at all times. The mean score was 23 (0 to 59.6) in the non-operative group and 22 (2.5 to 57.8) in the operative group, one year after the injury (p = 0.763). There was no significant difference between groups in the secondary outcome measures of the Broberg and Morrey Score or the Mayo Elbow Score at any time during the one year following injury (all p ≥ 0.05). . Conclusion. These data further support the role of primary non-operative management of isolated displaced fractures of the olecranon in the elderly. However, the non-inferiority of non-operative management cannot be proved as the trial was stopped prematurely. Cite this article: Bone Joint J 2017;99-B:964–72

Aims

Our aim, using English Hospital Episode Statistics data before during and after the Distal Radius Acute Fracture Fixation Trial (DRAFFT), was to assess whether the results of the trial affected clinical practice.

Our aim was to compare polylevolactic acid screws with titanium screws when used for fixation of the distal tibiofibular syndesmosis at mid-term follow-up. A total of 168 patients, with a mean age of 38.5 years (18 to 72) who were randomly allocated to receive either polylevolactic acid (n = 86) or metallic (n = 82) screws were included. The Baird scoring system was used to assess the overall satisfaction and functional recovery post-operatively. The demographic details and characteristics of the injury were similar in the two groups. The mean follow-up was 55.8 months (48 to 66). The Baird scores were similar in the two groups at the final follow-up. Patients in the polylevolactic acid group had a greater mean dorsiflexion (p = 0.011) and plantar-flexion of the injured ankles (p < 0.001). In the same group, 18 patients had a mild and eight patients had a moderate foreign body reaction. In the metallic groups eight had mild and none had a moderate foreign body reaction (p <  0.001). In total, three patients in the polylevolactic acid group and none in the metallic group had heterotopic ossification (p = 0.246).

We conclude that both screws provide adequate fixation and functional recovery, but polylevolactic acid screws are associated with a higher incidence of foreign body reactions.

Cite this article: Bone Joint J 2014;96-B:548–54.

It remains a matter of debate whether displaced fractures of the neck of the femur should be treated by internal fixation or arthroplasty. We have compared the two methods with regard to complications, mortality and functional outcome.

We studied 409 patients, aged 70 years and over, with subcapital fractures graded as Garden 3 or 4, in a two-year prospective multicentre study from 12 Swedish hospitals. They were randomised to internal fixation or arthroplasty. Patients who were mentally confused, bedridden or in a nursing-home were excluded from the survey.

After two years the rate of failure was 43% in the internal fixation (IF) and 6% in the arthroplasty group (p < 0.001). In the IF group 36% had impaired walking and 6% had severe pain compared with 25% and 1.5%, respectively, in the arthroplasty group (both p < 0.05). There was no difference in mortality.

With a high rate of failure and poor functional outcome after IF, we recommend primary arthroplasty for displaced fractures of the neck of the femur in patients over 70 years of age.

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

We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study.

A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients’ age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware.

We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p < 0.001, and 97.9 vs 81.2 minutes, p < 0.001, respectively). After one year, all the fractures had united. Patients who had intramedullary nailing had a higher mean pain score, but better function, alignment and total American Orthopaedic Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed.

We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with these fractures.

This study compares the cost-effectiveness of treating dorsally displaced distal radial fractures with a volar locking plate and percutaneous fixation. It was performed from the perspective of the National Health Service (NHS) using data from a single-centre randomised controlled trial. In total 130 patients (18 to 73 years of age) with a dorsally displaced distal radial fracture were randomised to treatment with either a volar locking plate (n = 66) or percutaneous fixation (n = 64). The methodology was according to National Institute for Health and Care Excellence guidance for technology appraisals. . There were no significant differences in quality of life scores between groups at any time point in the study. Both groups returned to baseline one year post-operatively. . NHS costs for the plate group were significantly higher (p < 0.001, 95% confidence interval 497 to 930). For an additional £713, fixation with a volar locking plate offered 0.0178 additional quality-adjusted life years in the year after surgery. The incremental cost-effectiveness ratio (ICER) for plate fixation relative to percutaneous fixation at list price was £40 068. When adjusting the prices of the implants for a 20% hospital discount, the ICER was £31 898. Patients who underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from the perspective of the NHS, of fixation using a volar locking plate over percutaneous fixation for the operative treatment of a dorsally displaced radial fracture. Cite this article: Bone Joint J 2015;97-B:1264–70

The ideal form of fixation for displaced, extra-articular fractures of the distal tibia remains controversial. In the UK, open reduction and internal fixation with locking-plates and intramedullary nailing are the two most common forms of treatment. Both techniques provide reliable fixation but both are associated with specific complications. There is little information regarding the functional recovery following either procedure. We performed a randomised pilot trial to determine the functional outcome of 24 adult patients treated with either a locking-plate (n = 12) or an intramedullary nailing (n = 12). At six months, there was an adjusted difference of 13 points in the Disability Rating Index in favour of the intramedullary nail. However, this was not statistically significant in this pilot trial (p = 0.498). A total of seven patients required further surgery in the locking-plate group and one in the intramedullary nail group. This study suggests that there may be clinically relevant, functional differences in patients treated with nail versus locking-plate fixation for fractures of the distal tibia and differences in related complications. Further trials are required to confirm the findings of this pilot investigation

Aims. Fractures of the distal femur are an important cause of morbidity. Their optimal management remains controversial. Contemporary implants include angular-stable anatomical locking plates and locked intramedullary nails (IMNs). We compared the long-term patient-reported functional outcome of fixation of fractures of the distal femur using these two methods of treatment. Patients and Methods. A total of 297 patients were retrospectively identified from a State-wide trauma registry in Australia: 195 had been treated with a locking plate and 102 with an IMN. Baseline characteristics of the patients and their fractures were recorded. Health-related quality-of-life, functional and radiographic outcomes were compared using mixed effects regression models at six months and one year. Results. There was a clinically relevant and significant difference in quality-of-life at six months in favour of fixation with an IMN (mean difference in EuroQol-5 Dimensions Score (EQ-5D) = 0.12; 95% CI 0.02 to 0.22; p = 0.025). There was weak evidence that this trend continued to one year (mean difference EQ-5D = 0.09; 95% CI -0.01 to 0.19; p = 0.073). There was a significant although very small reduction in angular deformity using an IMN (mean difference -1.02; 95% CI -1.99 to -0.06; p = 0.073). There was no evidence that there was a difference in any other outcomes at any time point. Take home message: IMN may be a superior treatment compared with anatomical locking plates for fractures of the distal femur. These findings are concordant with other data from pilot randomised studies which favour treatment of these fractures with an IMN. This study strongly supports the need for a definitive randomised trial. Cite this article: Bone Joint J 2016;98-B:846–50

Objectives. The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery. Methods. A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included. Results. The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders. Conclusions. The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery. Cite this article: J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. Bone Joint Res 2017;6:423–432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1

In a randomised trial involving 598 patients with 600 trochanteric fractures of the hip, the fractures were treated with either a sliding hip screw (n = 300) or a Targon PF intramedullary nail (n = 300). The mean age of the patients was 82 years (26 to 104). All surviving patients were reviewed at one year with functional outcome assessed by a research nurse blinded to the treatment used. The intramedullary nail was found to have a slightly increased mean operative time (46 minutes (. sd. 12.3) versus 49 minutes (. sd. 12.7), p < 0.001) and an increased mean radiological screening time (0.3 minutes (. sd. 0.2) versus 0.5 minutes (. sd. 0.3), p <  0.001). Operative difficulties were more common with the intramedullary nail. There was no statistically significant difference between implants for wound healing complications (p = 1), or need for post-operative blood transfusion (p = 1), and medical complications were similarly distributed in both groups. There was a tendency to fewer revisions of fixation or conversion to an arthroplasty in the nail group, although the difference was not statistically significant (nine versus three cases, p = 0.14). The extent of shortening, loss of hip flexion, mortality and degree of residual pain were similar in both groups. The recovery of mobility was superior for those treated with the intramedullary nails (p = 0.01 at one year from injury). In summary, both implants produced comparable results but there was a tendency to better return of mobility for those treated with the intramedullary nail

Objectives . A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods . These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. Results. All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. Conclusion . In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40

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

Aims. This is a prospective randomised controlled trial comparing the functional outcomes of plate fixation and elastic stable intramedullary nailing (ESIN) of completely displaced mid-shaft fractures of the clavicle in the active adult population. Patients and Methods. We prospectively recruited 123 patients and randomised them to either plate fixation or ESIN. Patients completed the Quick Disabilities of the Arm, Shoulder and Hand (DASH) score at one to six weeks post-operatively. They were followed up at six weeks, three and six months and one year with radiographs, and their clinical outcome was assessed using both the DASH and the Constant Score. Results. Plate fixation provided a faster functional recovery during the first six months compared with ESIN, but there was no difference after one year. The duration of surgery was shorter for ESIN (mean 53.4 minutes, 22 to 120) than for plate fixation (mean 69.7 minutes, 35 to 106, p < 0.001). The recovery after ESIN was slower with increasing fracture comminution and with open reduction (p < 0.05). Conclusion. Both methods return the patients to their pre-injury functional levels, but plate fixation has a faster recovery period in comminuted fractures than ESIN. ESIN has a shorter operative time and lower infection and implant rates of failure when using 2.5 mm nails or wider, suggesting that this is the preferred method in mid-shaft fractures with no comminution, whereas plate fixation is the superior method in comminuted fractures. Cite this article: Bone Joint J 2017;99-B:1095–1101

We have compared the results of simple patellectomy (group A, n = 16) and patellectomy with advancement of the vastus medialis obliquus (group B, n = 12) in a prospective, randomised trial, with a minimum follow-up of three years. The results in group B were significantly better (p < 0.001) than those in group A. Although the patella should be preserved if possible, we advocate advancement of the vastus medialis obliquus when patellectomy is necessary

Aims. This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial. Patients and Methods. Data for patients’ use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated. Results. With a cost per device of $3,995, the mean cost was significantly higher for patients treated with LIPUS versus placebo from a payer (mean increase = $3647, 95% confidence interval (CI) $3244 to $4070; p < 0.001) or a societal perspective (mean increase = $3425, 95% CI $1568 to $5283; p < 0.001). LIPUS did not provide a significant benefit in terms of QALYs gained (mean difference = 0.023 QALYs, 95% CI -0.035 to 0.069; p = 0.474). Incremental cost-effectiveness ratios of LIPUS compared with placebo were $155 433/QALY from a payer perspective and $146 006/QALY from a societal perspective. Conclusion. At the current price, LIPUS is not cost-effective for fresh tibial fractures managed with intramedullary nailing. Cite this article: Bone Joint J 2017;99-B:1526–32

We performed a prospective, randomised trial on 120 patients with redisplaced fractures of the distal radius comparing four methods of treatment. The four treatment groups, each containing 30 patients, were remanipulation and plaster, open reduction and bone grafting, and closed external fixation with and without mobilisation of the wrist at three weeks. The radiological results showed improvement in angulation of the distal radius for the open reduction and bone grafting group. Functional results at six weeks, three and six months and at one year, however, showed no difference between any of the four groups. The main influence on final outcome was carpal malalignment which had a statistically significant negative effect on function

Our study was designed to compare the effect of indometacin with that of a placebo in reducing the incidence of heterotopic ossification in a prospective, randomised trial. A total of 121 patients with displaced fractures of the acetabulum treated by operation through a Kocher-Langenbeck approach was randomised to receive either indometacin (75 mg) sustained release, or a placebo once daily for six weeks. The extent of heterotopic ossification was evaluated on plain radiographs three months after operation. Significant ossification of Brooker grade III to IV occurred in nine of 59 patients (15.2%) in the indometacin group and 12 of 62 (19.4%) receiving the placebo. We were unable to demonstrate a statistically significant reduction in the incidence of severe heterotopic ossification with the use of indometacin when compared with a placebo (p = 0.722). Based on these results we cannot recommend the routine use of indometacin for prophylaxis against heterotopic ossification after isolated fractures of the acetabulum

We performed a prospective, randomised trial in 39 patients with open tibial fractures treated initially by external fixation to compare cast immobilisation (group A) and intramedullary nailing (group B) as a sequential protocol planned from the onset of treatment. The results showed that group B achieved faster union (p < 0.05) than group A with less malunion or shortening and a greater range of movement. Patients treated by intramedullary nailing required fewer radiographs and outpatient visits (p = 0.0015) and had a more predictable and rapid return to full function. We feel that these severe fractures are better treated by delayed intramedullary nailing and that this has an acceptable rate of complications

In a prospective, randomised trial of 81 patients with fractures of the ankle of AO types A, B and C we compared two regimes of postoperative management after internal fixation. The patients were mobilised either non-weight-bearing with crutches or weight-bearing in a below-knee walking plaster. We found a temporary benefit in subjective evaluation only (65 v 50 points, Mann-Whitney test, cft, p = 0.02) for those with a below-knee walking plaster. There were no significant differences between the groups in the loaded dorsal range of movement (25° v 23°, Mann-Whitney test, cft, p = 0.16) or in the overall clinical result. Both treatments were considered to be satisfactory and their choice depends on the ability to mobilise non-weight-bearing, wound healing, the type of work and personal preference