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

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

A total of 56 male patients with a displaced intracapsular fracture of the hip and a mean age of 81 years (62 to 94), were randomised to be treated with either a cemented hemiarthroplasty (the Exeter Trauma Stem) or reduction and internal fixation using the Targon Femoral Plate. All surviving patients were reviewed one year after the injury, at which time restoration of function and pain in the hip was assessed. There was no statistically significant difference in mortality between the two groups (7/26; 26.9% for hemiarthroplasty vs 10/30; 33.3% for internal fixation). No patient treated with a hemiarthroplasty required further surgery, but eight patients treated by internal fixation did (p = 0.005), five requiring hemiarthroplasty and three requiring total hip arthroplasty. Those treated by internal fixation had significantly more pain (p = 0.02). The restoration of mobility and independence were similar in the two groups.

These results indicate that cemented hemiarthroplasty gives better results than internal fixation in elderly men with a displaced intracapsular fracture of the hip.

Cite this article: Bone Joint J 2015;97-B:992–6.

Introduction. The knee is the most commonly injured joint in sporting accidents, leading to substantial disability, time off work and morbidity (1). Treatment and assessment vary around the UK (2), whilst there remains a limited number of high-quality randomised controlled trials assessing first time, acute soft tissue knee injuries (3,4). As the clinical and financial burden rises (5), vital answers are required to improve prevention, diagnosis, treatment, rehabilitation, and delivery of care. In association with the James Lind Alliance, this BASK, BOSTAA and BOA supported prioritising exercise was undertaken over a year. Methods. The James Lind Alliance methodology was followed; a modified nominal group technique was used in the final workshop. An initial survey invited patients and healthcare professionals to submit their uncertainties regarding soft tissue knee injury prevention, diagnosis, treatment, rehabilitation, and delivery of care. Seventy-four questions were formulated to encompass common concerns. These were checked against best available evidence. Following the interim survey, 27 questions were taken forward to the final workshop in January 2023, where they were discussed, ranked, and scored in multiple rounds of prioritisation by groups of healthcare professionals, patients, and carers. Results. Over 1000 questions were submitted initially. Twenty-seven were taken forward to the final workshop following the surveys. Nearly half of the responses were from patients/carers. The Top 10 (Figure 1) includes prevention, diagnosis, treatment, and rehabilitation questions, reflecting the concerns of patients, carers, and a wider multidisciplinary team. Conclusion. This validated process has generated an important, wide- ranging Top 10 priorities for future soft tissue knee injury research. These have been submitted to the National Institute for Health and Care Research and are now available for researchers to investigate. The final 27 questions which were taken to the final workshop have also been published on the James Lind Alliance website. Research into these questions will lead to future high-quality research, thus improving patient care & outcomes. For any figures or tables, please contact authors directly

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

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

The objective of this study was to compare differences in alignment following robotic arm-assisted bi-unicompartmental knee arthroplasty (Bi-UKA) and conventional total knee arthroplasty (TKA). This was a prospective, randomised controlled trial of 70 patients. 39 TKAs were implanted manually, as per standard protocol at our institution, and 31 Bi-UKA patients simultaneously received fixed-bearing medial and lateral UKAs, implanted using robotic arm-assistance. Preoperative and 3-month postoperative CT scans were analysed to determine hip knee ankle angle (HKAA), medial distal femoral angle (MDFA), and medial proximal tibial angle (MPTA). Analysis was repeated for 10 patients by a second rater to validate measurement reliability by calculating the intra-class correlation coefficient (ICC). Mean change in HKAA towards neutral was 2.7° in TKA patients and 2.3° in Bi-UKA patients (P=0.6). Mean change in MDFA was 2.5° for TKA and 1.0° for Bi-UKA (P<0.01). Mean change in MPTA was 3.7° for TKA and 0.8° for Bi-UKA (P<0.01). Mean postoperative MDFA and MPTA for TKAs were 89.8° and 89.6° respectively, indicating orientation of femoral and tibial components perpendicular to the mechanical axis. Mean postoperative MDFA and MPTA for Bi-UKAs were 91.0° and 86.9° respectively, indicating a more oblique joint line orientation. Inter-rater agreement was excellent (ICC>0.99). Early functional activities, according to the new Knee Society Scoring System, favoured Bi-UKAs (P<0.05). Robotic arm-assisted, cruciate-sparing Bi-UKA better maintains the natural anatomy of the knee in the coronal plane and may therefore preserve normal joint kinematics, compared to a mechanically aligned TKA. This has been achieved without significantly altering overall HKAA

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

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

The primary aim of this study was to undertake a cost-effectiveness analysis (CEA) of acute fixation versus conservative management of displaced midshaft clavicle fractures. The secondary aim was to conduct a sensitivity analysis of patient characteristics that may influence a threshold of £20,000 per quality-adjusted life year gained (QALY). A CEA was conducted from a randomised control trial comparing conservative management (n=92) to acute plate fixation (n=86) of displaced midshaft clavicle fractures. The incremental cost effectiveness ratio (ICER) was used to express the cost per QALY. The short form 6-dimensional (SF-6D) score was the preference based index to calculate the cost per QALY. The 12-month SF-6D advantage of acute fixation over conservative management was 0.0085 (p=0.464) with a mean cost difference of £4,096.22 and resultant ICER of £481,908.24/QALY. For a threshold of £20,000/QALY the benefit of acute fixation would need to be present for 24.1 years. Linear regression analysis identified nonunion as the only independent factor to influence the SF-6D at 12-months (p<0.001). Conservatively managed fractures that resulted in a nonunion (n=16) had a significantly worse SF-6D compared to acute fixation (0.0723, p=0.001) with comparable healthcare cost at 12-months (£170.12 difference). Modelling the ICER of acute fixation against those complicated by a nonunion proved to be cost effective at £2,352.97/QALY at 12-months. Routine plate fixation of displaced midshaft clavicle fractures is not cost-effective. Patients with nonunion after conservative management have increased morbidity with comparable expense to those undergoing acute fixation which suggests targeting these patients is a more cost-effective strategy

Limited long term data exists comparing operatively and non-operatively treated Achilles tendon ruptures. A previous randomised controlled trial comparing early outcomes showed a short term advantage for surgery, but there are no long term prospective randomised comparisons. Our aim was to determine whether surgery conferred long term benefits in terms of patient reported outcomes or re-rupture. 64 patients (80%) were followed up with postal questionnaires. Patients were asked to complete the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS) and EQ-5D questionnaires, and to report re-ruptures. 32 patients were treated non-operatively and 32 operatively; 59 completed the SMFA and 64 the ATRS and EQ-5D assessments. There was no significant difference in SMFA score (median 1.09, IQR 4.89 in the cast group versus 2.17 and 7.07 in the operative group; p=0.347), ATRS (median 96, IQR 18 versus 93 and 15; p=0.509), EQ-5D Index (median 1.0, IQR 0.163 versus 1.0 and 0.257; p=0.327) and EQ-5D Visual Analogue Score (median score 85, IQR 15 versus 85 and 24; p=0.650). There were 2 re-ruptures in the operative group and 4 in the non-operative group (p=0.067). This is the first prospective, randomised, long term report comparing operative and non-operative management. At follow up between 13–17 years after injury, patients reported good function and health related quality of life. There was no significant difference in re-rupture rate between the treatment groups

We undertook a prospective randomised controlled trial involving 400 patients with a displaced intracapsular fracture of the hip to determine whether there was any difference in outcome between treatment with a cemented Thompson hemiarthroplasty and an uncemented Austin-Moore prosthesis. The surviving patients were followed up for between two and five years by a nurse blinded to the type of prosthesis used. The mean age of the patients was 83 years (61 to 104) and 308 (77%) were women. The degree of residual pain was less in those treated with a cemented prosthesis (p < 0.0001) three months after surgery. Regaining mobility was better in those treated with a cemented implant (p = 0.005) at six months after operation. No statistically significant difference was found between the two groups with regard to mortality, implant-related complications, re-operations or post-operative medical complications. The use of a cemented Thompson hemiarthroplasty resulted in less pain and less deterioration in mobility than an uncemented Austin-Moore prosthesis with no increase in complications

Background. Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. Design. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset. Discussion. Evidence on the optimum choice of prosthesis for hemiarthroplasty of the hip is lacking. National guidance is currently based on expert opinion rather than empirical evidence. The incidence of hip fracture is likely to continue to increase and providing high quality evidence on the optimum treatment will improve patient outcomes and have important health economic implications. Cite this article: A. L. Sims. The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation – WH. I. TE 3: HEMI – An Abridged Protocol. Bone Joint Res 2016;5:18–25. doi: 10.1302/2046-3758.51.2000473

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

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. . Results. Patients randomised to receive surgical intervention accumulated mean greater costs and marginally lower QALYs than patients randomised to non-surgery. The surgical intervention cost a mean of £1758 more per patient (95% confidence intervals (CI) £1126 to £2389). Total QALYs for the surgical group were smaller than those for non-surgery -0.0101 (95% CI -0.13 to 0.11). The probability of surgery being cost effective was less than 10% given the current NICE willingness to pay at a threshold of £20 000 for an additional QALY. The results were robust to sensitivity analyses. Discussion. The results suggest that current surgical treatment is not cost effective for the majority of displaced fractures of the proximal humerus involving the surgical neck in the United Kingdom’s NHS. Take home message: The results of this trial do not support the trend of increased surgical treatment for patients with displaced fractures of the proximal humerus involving the surgical neck within the United Kingdom NHS. Cite this article: Bone Joint J 2016;98-B:152–9

We conducted a randomised controlled trial to compare external fixation of trochanteric fractures of the femur with the more costly option of the sliding hip screw. Patients in both groups were matched for age (mean 67 years, 50 to 100) and gender. We excluded all pathological fractures, patients presenting at more than one week, fractures with subtrochanteric extension or reverse obliquity, multiple fractures or any bone and joint disease interfering with rehabilitation. The interval between injury and operation, the duration of surgery, the amount of blood loss, the length of hospital stay and the cost of treatment were all significantly higher in the sliding hip screw group (p < 0.05). The time to union, range of movement, mean Harris hip scores and Western Ontario and McMaster University knee scores were comparable at six months. The number of patients showing shortening or malrotation was too small to show a significant difference between the groups. Pin-track infection occurred in 18 patients (60%) treated with external fixation, whereas there was a single case of wound infection (3.3%) in the sliding hip screw group

The best surgical treatment of lateral epicondylitis remains uncertain. Recently radiofrequency microtenotomy (RFMT) has been proposed as a suitable surgical treatment. We aim to compare open release with RFMT and present the results of our randomised controlled trial. Patients with symptoms of tennis elbow for at least 6 months who had failed to respond to conservative management were included in the trial. They were randomised to open release or RFMT. Outcome measures included grip strength, pain and DASH scores. 41 patients were randomised, 23 to RFMT and 18 to open release, 2 patients withdrew from the study. Our results show that both treatments give a significant benefit at all time points for DASH and pain scores, but only open release gives a significant improvement in grip strength. Comparing the two treatments the only significant difference is the open group have better pain scores at 6 weeks, but this is not seen at later follow up. In conclusion both groups have shown benefit from the treatments, but one is not shown to be clearly superior

There is limited long term evidence to support instrumented fusion as an adjunct to decompression for foraminal stenosis in the presence of single level degenerative disc disease. We report the long term outcome of a prospective randomised controlled trial. Forty-four patients with single-level disc disease were randomly assigned to three groups (spinal decompression (Group 1), decompression and instrumented posterolateral fusion (Group 2), or decompression and instrumented posterolateral fusion plus transforaminal interbody fusion (Group 3). Spinal disability (Dallas, Roland Morris, and Lower Back Outcome Score [LBOS]), and quality of life (EuroQol (EQ) and short form (SF-) 36 questionnaires) were assessed before and at after surgery by independent researchers. At mean of 15 years follow up 33 (75%) patients were available for assessment. All groups observed a significant improvement in the EQ-5D at final follow up. Group 1 demonstrated significantly better functional outcome at final follow up according to the Dallas, Roland Morris, LBOS, and EQ-5D (3L and VAS) scores when compared to the other two groups (p<0.01). The SF-36 score demonstrated that group 1 had significantly better generic health scores compared to groups 2 and 3. Regression analysis was used to adjust for the differences in general health between the groups and demonstrated no significant difference between the groups in the spine specific scores: Dallas (p>0.15), Roland Morris (p>0.37), or the LBOS (p>0.32). Fusion in combination with decompression for the treatment of foraminal stenosis and single level degenerative disc disease offers no long term functional benefit over decompression in isolation

There is a paucity of published literature regarding the long-term outcomes of the modern generations of total joint arthroplasty (TJA) of the first metatarsophalangeal joint. Between 1999 and 2001, we recruited 63 patients into a randomised controlled trial of arthrodesis vs TJA. The 2 year results were published in 2005. At a mean follow-up 15.2 years (range 13.2–17.2), all patients from the original trial were contacted. Data were collected in the form of visual analogue score for pain (VAS), visual-Analogue-Scale Foot and Ankle (VAS FA) as well as information on any revision procedures. Data were available from all surviving patients (66 toes 53 patients). There was no difference in pain scores between the arthrodesis group and arthroplasty group 7.4 ± 15.7 vs 15.7 ± 19.7 (p=0.06). There was also no difference in the VAS FA scores as a whole 88.9 ± 12.9 vs 86.1 ± 17.1 (p = 0.47), or when divided into its 3 components (pain, function and other complaints). There was however a significant difference with regards to patient satisfaction with the arthrodesis group outperforming the TJA group: 95.5 ± 10.4 vs 83.6 ± 20.9 (p<0.01). There was a significantly higher rate of revision surgery in the TJA group when compared to the arthrodesis group (p= 0.009). At 15 years the patients that underwent arthrodesis were more satisfied and had a greater survivorship compared to TJA, however there was no difference in outcome with regards to pain or function between the two groups. Based on the results of this study arthrodesis remains the ‘gold standard’ due to excellent pain relief, high function and low risk of revision surgery

We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing