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Bone & Joint Research
Vol. 5, Issue 1 | Pages 18 - 25
1 Jan 2016
Sims AL Parsons N Achten J Griffin XL Costa ML Reed MR

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


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


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 964 - 972
1 Jul 2017
Duckworth AD Clement ND McEachan JE White TO Court-Brown CM McQueen MM

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


Bone & Joint Research
Vol. 3, Issue 12 | Pages 335 - 340
1 Dec 2014
Handoll HHG Goodchild L Brealey SD Hanchard NCA Jefferson L Keding A Rangan A

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


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1399 - 1405
1 Oct 2016
Rohilla R Wadhwani J Devgan A Singh R Khanna M

Aims. This is a prospective randomised study which compares the radiological and functional outcomes of ring and rail fixators in patients with an infected gap (> 3 cm) nonunion of the tibia. Patients and Methods. Between May 2008 and February 2013, 70 patients were treated at our Institute for a posttraumatic osseocutaneous defect of the tibia measuring at least 3 cm. These were randomised into two groups of 35 patients using the lottery method. Group I patients were treated with a ring fixator and group II patients with a rail fixator. The mean age was 33.2 years (18 to 64) in group I and 29.3 years (18 to 65) in group II. The mean bone gap was 5.84 cm in group I and 5.78 cm in group II. The mean followup was 33.8 months in group I and 32.6 months in group II. Bone and functional results were assessed using the classification of the Association for the Study and Application of the Method of Ilizarov (ASAMI). Functional results were also assessed at six months using the short musculoskeletal functional assessment (SMFA) score. Results. The bone result was excellent, good, fair and poor in 21, 12, 0 and 2 in group I; and 14, 15, 3, and 3 in group II, respectively. The functional results were excellent, good, fair, poor and failure in 16, 17, 1, 0 and 1 in group I; and 22, 10, 0, 3 and 0 in group II, respectively. Both fixator systems achieved comparable rates of union and functional outcomes. The rate of deep pintract infection was significantly higher in the rail fixator group but patients found it more comfortable. Conclusion. We recommend the use of a ring fixator in patients with a bone gap of more than 6 cm. Patients with a bone gap up to 6 cm can be managed with either a ring or rail fixator. Cite this article: Bone Joint J 2016;98B:1399–1405


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 9 | Pages 1210 - 1217
1 Sep 2007
Peyser A Weil YA Brocke L Sela Y Mosheiff R Mattan Y Manor O Liebergall M

Limited access surgery is thought to reduce post-operative morbidity and provide faster recovery of function. The percutaneous compression plate (PCCP) is a recently introduced device for the fixation of intertrochanteric fractures with minimal exposure. It has several potential mechanical advantages over the conventional compression hip screw (CHS). Our aim in this prospective, randomised, controlled study was to compare the outcome of patients operated on using these two devices. We randomised 104 patients with intertrochanteric fractures (AO/OTA 31.A1–A2) to surgical treatment with either the PCCP or CHS and followed them for one year postoperatively. The mean operating blood loss was 161.0 ml (8 to 450) in the PCCP group and 374.0 ml (11 to 980) in the CHS group (Student’s t-test, p < 0.0001). The pain score and ability to bear weight were significantly better in the PCCP group at six weeks post-operatively. Analysis of the radiographs in a proportion of the patients revealed a reduced amount of medial displacement in the PCCP group (two patients, 4%) compared with the CHS group (10 patients, 18.9%); Fisher’s exact test, p < 0.02. The PCCP device was associated with reduced intra-operative blood loss, less postoperative pain and a reduced incidence of collapse of the fracture


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 5 | Pages 704 - 708
1 May 2012
Mauffrey C McGuinness K Parsons N Achten J Costa ML

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


The Bone & Joint Journal
Vol. 98-B, Issue 9 | Pages 1248 - 1252
1 Sep 2016
White TO Bugler KE Appleton P Will† E McQueen MM Court-Brown CM

Aims. The fundamental concept of open reduction and internal fixation (ORIF) of ankle fractures has not changed appreciably since the 1960s and, whilst widely used, is associated with complications including wound dehiscence and infection, prominent hardware and failure. Closed reduction and intramedullary fixation (CRIF) using a fibular nail, wires or screws is biomechanically stronger, requires minimal incisions, and has low-profile hardware. We hypothesised that fibular nailing in the elderly would have similar functional outcomes to standard fixation, with a reduced rate of wound and hardware problems. Patients and Methods. A total of 100 patients (25 men, 75 women) over the age of 65 years with unstable ankle fractures were randomised to undergo standard ORIF or fibular nailing (11 men and 39 women in the ORIF group, 14 men and 36 women in the fibular nail group). The mean age was 74 years (65 to 93) and all patients had at least one medical comorbidity. Complications, patient related outcome measures and cost-effectiveness were assessed over 12 months. Results. Significantly fewer wound infections occurred in the fibular nail group (p = 0.002). At one year, there was no evidence of difference in mean functional scores (Olerud and Molander Scores 63; 30 to 85, versus 61; 10 to 35, p = 0.61) or scar satisfaction. The overall cost of treatment in the fibular nail group was £91 less than in the ORIF group despite the higher initial cost of the implant. Conclusion. We conclude that the fibular nail allows accurate reduction and secure fixation of ankle fractures, with a significantly lower rate of soft-tissue complications, and is more cost-effective than ORIF. Cite this article: Bone Joint J 2016;98-B:1248–52


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 7 | Pages 984 - 988
1 Jul 2010
Guo JJ Tang N Yang HL Tang TS

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


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 2 | Pages 183 - 188
1 Mar 2002
Rogmark C Carlsson Å Johnell O Sernbo I

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


The Bone & Joint Journal
Vol. 98-B, Issue 3 | Pages 410 - 413
1 Mar 2016
Costa ML Jameson SS Reed MR

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.

Patients and Methods

Data were grouped into six month intervals from July 2005 to December 2014. All patient episodes in the National Health Service involving emergency surgery for an isolated distal radial fracture were included.


The Bone & Joint Journal
Vol. 96-B, Issue 4 | Pages 548 - 554
1 Apr 2014
Sun H Luo CF Zhong B Shi HP Zhang CQ Zeng BF

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.


The Bone & Joint Journal
Vol. 99-B, Issue 8 | Pages 1095 - 1101
1 Aug 2017
Fuglesang HFS Flugsrud GB Randsborg PH Oord P Benth JŠ Utvåg SE

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 Bone & Joint Journal
Vol. 99-B, Issue 4 | Pages 494 - 502
1 Apr 2017
Simpson AHRW Keenan G Nayagam S Atkins RM Marsh D Clement ND

Aims. The aim of this double-blind prospective randomised controlled trial was to assess whether low intensity pulsed ultrasound (LIPUS) accelerated or enhanced the rate of bone healing in adult patients undergoing distraction osteogenesis. Patients and Methods. A total of 62 adult patients undergoing limb lengthening or bone transport by distraction osteogenesis were randomised to treatment with either an active (n = 32) or a placebo (n = 30) ultrasound device. A standardised corticotomy was performed in the proximal tibial metaphysis and a circular Ilizarov frame was used in all patients. The rate of distraction was also standardised. The primary outcome measure was the time to removal of the frame after adjusting for the length of distraction in days/cm for both the per protocol (PP) and the intention-to-treat (ITT) groups. The assessor was blinded to the form of treatment. A secondary outcome was to identify covariates affecting the time to removal of the frame. Results. There was no difference in the time to removal of the frame between the PP (difference in favour of the control group was 10.1 days/cm, 95% confidence interval (CI) -3.2 to 23.4, p = 0.054) or ITT (difference 5.0 days/cm, 95% CI -8.2 to 18.21, p = 0.226) groups. The smoking status was the only covariate which increased the time to removal of the frame (hazard ratio 0.47, 95% CI 0.22 to 0.97, p = 0.042). Conclusion. LIPUS does not influence the rate of bone healing in patients who undergo distraction osteogenesis. Smoking may influence bone healing. . Cite this article: Bone Joint J 2017;99-B:494–502


Bone & Joint Research
Vol. 6, Issue 7 | Pages 423 - 432
1 Jul 2017
van der Stok J Hartholt KA Schoenmakers DAL Arts JJC

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

Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance.

Methods

We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs.


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 846 - 850
1 Jun 2016
Hoskins W Sheehy R Edwards ER Hau RC Bucknill A Parsons N Griffin XL

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


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1562 - 1565
1 Nov 2015
Ersen A Atalar AC Birisik F Saglam Y Demirhan M

Only a few randomised, controlled studies have compared different non-operative methods of treatment of mid-shaft fractures of the clavicle. . In this prospective, randomised controlled study of 60 participants (mean age 31.6 years; 15 to 75) we compared the broad arm sling with the figure of eight bandage for the treatment of mid-shaft clavicle fractures. Our outcome measures were pain, Constant and American Shoulder and Elbow Surgeons scores and radiological union. The mean visual analogue scale (VAS) pain score on the first day after treatment was significantly higher (VAS 1 6.8; 4 to 9) in the figure of eight bandage group than the broad arm sling group (VAS 1 5.6; 3 to 8, p = 0.034). A mean shortening of 9 mm (3 to 17) was measured in the figure of eight bandage group, versus 7.5 mm (0 to 24) in the broad arm sling group (p = 0.30). The application of the figure of eight bandage is more difficult than of the broad arm sling, and patients experience more pain during the first day when treated with this option. We suggest the broad arm sling is preferable because of the reduction of early pain and ease of application. Cite this article: Bone Joint J 2015;97-B:1562–5


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. . 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


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1264 - 1270
1 Sep 2015
Karantana A Scammell BE Davis TRC Whynes DK

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 Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1520 - 1525
1 Nov 2017
Haines N Kempton LB Seymour RB Bosse MJ Churchill C Hand K Hsu JR Keil D Kellam J Rozario N Sims S Karunakar MA

Aims. To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. 3. orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D. 3. . Cite this article: Bone Joint J 2017;99-B:1520–5


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1526 - 1532
1 Nov 2017
Tarride JE Hopkins RB Blackhouse G Burke N Bhandari M Johal H Guyatt GH Busse JW

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


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


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 Bone & Joint Journal
Vol. 99-B, Issue 2 | Pages 250 - 254
1 Feb 2017
Tol MCJM van den Bekerom MPJ Sierevelt IN Hilverdink EF Raaymakers ELFB Goslings JC

Aims. Our aim was to analyse the long-term functional outcome of two forms of surgical treatment for active patients aged > 70 years with a displaced intracapsular fracture of the femoral neck. Patients were randomised to be treated with either a hemiarthroplasty or a total hip arthroplasty (THA). The outcome five years post-operatively for this cohort has previously been reported. We present the outcome at 12 years post-operatively. Patients and Methods. Initially 252 patients with a mean age of 81.1 years (70.2 to 95.6) were included, of whom 205 (81%) were women. A total of 137 were treated with a cemented hemiarthroplasty and 115 with a cemented THA. At long-term follow-up we analysed the modified Harris Hip Score (HHS), post-operative complications and intra-operative data of the patients who were still alive. Results . At a mean follow-up of 12 years (8.23 to 16.17, standard deviation 2.24), 50 patients (20%), 32 in the hemiarthroplasty group and 18 in the THA group, were still alive, of which 47 (94%) were women. There were no significant differences in the mean modified HHS (p = 0.85), mortality (p = 0.13), complications (p = 0.93) or rate of revision surgery (p = 1.0) between the two groups. Conclusion. In the treatment of active elderly patients with an intracapsular fracture of the hip there is no difference in the functional outcome between hemiarthroplasty and THA treatments at 12 years post-operatively. Cite this article: Bone Joint J 2017;99-B:250–4


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 3 | Pages 388 - 394
1 Mar 2009
Goel DP Buckley R deVries G Abelseth G Ni A Gray R

The incidence of deep-vein thrombosis and the need for thromboprophylaxis following isolated trauma below the knee is uncertain. We have investigated this with a prospective randomised double-blind controlled trial using low molecular weight heparin with saline injection as placebo in patients aged between 18 and 75 years who had sustained an isolated fracture below the knee which required operative fixation. All patients had surgery within 48 hours of injury and were randomised to receive either the placebo or low molecular weight heparin for 14 days, after which they underwent bilateral lower limb venography, interpreted by three independent radiologists. Further follow-up was undertaken at two, six, eight and 12 weeks. A total of 238 patients fulfilled all the inclusion criteria, with 127 in the low molecular weight heparin group and 111 in the placebo group, all of whom underwent bilateral venography. There was no statistically significant difference in the incidence of deep-vein thrombosis between those patients treated with low molecular weight heparin or the placebo (p = 0.22). The number of deep-vein thromboses in the two groups was 11 (8.7%) and 14 (12.6%), respectively. Age and the type of fracture were significantly associated with the rate of deep-vein thrombosis (p = 0.001 and p = 0.009, respectively) but gender, comorbidities and the body mass index were not. The overall incidence of deep-vein thrombosis in this series was 11%. There was no clinical or statistical significant reduction in the incidence of deep-vein thrombosis with the use of thromboprophylaxis. However, we accept that owing to a cessation of funding, recruitment to this trial had to be ended prior to establishing the necessary sample size. Our results cannot, therefore, categorically exclude the possibility that low molecular weight heparin treatment could be beneficial. We recommend a further multicentre trial be undertaken to resolve this matter


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 840 - 845
1 Jun 2016
Chesser TJS Fox R Harding K Halliday R Barnfield S Willett K Lamb S Yau C Javaid MK Gray AC Young J Taylor H Shah K Greenwood R

Aims. We wished to assess the feasibility of a future randomised controlled trial of parathyroid hormone (PTH) supplements to aid healing of trochanteric fractures of the hip, by an open label prospective feasibility and pilot study with a nested qualitative sub study. This aimed to inform the design of a future powered study comparing the functional recovery after trochanteric hip fracture in patients undergoing standard care, versus those who undergo administration of subcutaneous injection of PTH for six weeks. Patients and Methods. We undertook a pilot study comparing the functional recovery after trochanteric hip fracture in patients 60 years or older, admitted with a trochanteric hip fracture, and potentially eligible to be randomised to either standard care or the administration of subcutaneous PTH for six weeks. Our desired outcomes were functional testing and measures to assess the feasibility and acceptability of the study. Results. A total of 724 patients were screened, of whom 143 (20%) were eligible for recruitment. Of these, 123 were approached and 29 (4%) elected to take part. However, seven patients did not complete the study. Compliance with the injections was 11 out of 15 (73%) showing the intervention to be acceptable and feasible in this patient population. Take home message: Only 4% of patients who met the inclusion criteria were both eligible and willing to consent to a study involving injections of PTH, so delivering this study on a large scale would carry challenges in recruitment and retention. Methodological and sample size planning would have to take this into account. PTH administration to patients to enhance fracture healing should still be considered experimental. Cite this article: Bone Joint J 2016;98-B:840–5


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 12 | Pages 1613 - 1617
1 Dec 2006
Karunakar MA Sen A Bosse MJ Sims SH Goulet JA Kellam JF

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


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 Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 992 - 996
1 Jul 2015
Parker MJ

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


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 8 | Pages 1073 - 1078
1 Aug 2008
Little NJ Verma V Fernando C Elliott DS Khaleel A

We compared the outcome of patients treated for an intertrochanteric fracture of the femoral neck with a locked, long intramedullary nail with those treated with a dynamic hip screw (DHS) in a prospective randomised study. Each patient who presented with an extra-capsular hip fracture was randomised to operative stabilisation with either a long intramedullary Holland nail or a DHS. We treated 92 patients with a Holland nail and 98 with a DHS. Pre-operative variables included the Mini Mental test score, patient mobility, fracture pattern and American Society of Anesthesiologists grading. Peri-operative variables were anaesthetic time, operating time, radiation time and blood loss. Post-operative variables were time to mobilising with a frame, wound infection, time to discharge, time to fracture union, and mortality. We found no significant difference in the pre-operative variables. The mean anaesthetic and operation times were shorter in the DHS group than in the Holland nail group (29.7 vs 40.4 minutes, p < 0.001; and 40.3 vs 54 minutes, p < 0.001, respectively). There was an increased mean blood loss within the DHS group versus the Holland nail group (160 ml vs 78 ml, respectively, p < 0.001). The mean time to mobilisation with a frame was shorter in the Holland nail group (DHS 4.3 days, Holland nail 3.6 days, p = 0.012). More patients needed a post-operative blood transfusion in the DHS group (23 vs seven, p = 0.003) and the mean radiation time was shorter in this group (DHS 0.9 minutes vs Holland nail 1.56 minutes, p < 0.001). The screw of the DHS cut out in two patients, one of whom underwent revision to a Holland nail. There were no revisions in the Holland nail group. All fractures in both groups were united when followed up after one year. We conclude that the DHS can be implanted more quickly and with less exposure to radiation than the Holland nail. However, the resultant blood loss and need for transfusion is greater. The Holland nail allows patients to mobilise faster and to a greater extent. We have therefore adopted the Holland nail as our preferred method of treating intertrochanteric fractures of the hip


The Bone & Joint Journal
Vol. 98-B, Issue 5 | Pages 686 - 689
1 May 2016
Griffin XL Parsons N McArthur J Achten J Costa ML

Aims. The aim of this study was to inform a definitive trial which could determine the clinical effectiveness of the X-Bolt Dynamic Hip Plating System compared with the sliding hip screw for patients with complex pertrochanteric fragility fractures of the femur. Patients and Methods. This was a single centre, participant blinded, randomised, standard-of-care controlled pilot trial. Patients aged 60 years and over with AO/ASIF A2 and A3 type femoral pertrochanteric fractures were eligible. Results. The primary outcome was the EuroQoL 5 Dimension Score (EQ-5D-3L) at one year following index fixation. A total of 100 participants were recruited, and primary outcome data were available for 88 patients following losses to follow-up and withdrawals. The mean difference in EQ-5D was 0.03 (95% confidence interval -0.17, 0.120; p = 0.720.) There were no significant differences in any of the secondary outcomes measures. The recruitment and follow-up rates from this feasibility study were as predicted. Conclusion. A definitive trial with 90% power to find a clinically important difference in EQ-5D would require 964 participants based upon the data from this study. We plan to start recruitment to this trial in Spring 2016. Take home message: A definitive trial of X-Bolt Dynamic Hip Plating System is feasible and should be conducted now in order to quantify the clinical effectiveness of this novel implant. Cite this article: Bone Joint J 2016;98-B:686–9


The Bone & Joint Journal
Vol. 96-B, Issue 10 | Pages 1378 - 1384
1 Oct 2014
Weiser L Korecki MA Sellenschloh K Fensky F Püschel K Morlock MM Rueger JM Lehmann W

It is becoming increasingly common for a patient to have ipsilateral hip and knee replacements. The inter-prosthetic (IP) distance, the distance between the tips of hip and knee prostheses, has been thought to be associated with an increased risk of IP fracture. Small gap distances are generally assumed to act as stress risers, although there is no real biomechanical evidence to support this. The purpose of this study was to evaluate the influence of IP distance, cortical thickness and bone mineral density on the likelihood of an IP femoral fracture. A total of 18 human femur specimens were randomised into three groups by bone density and cortical thickness. For each group, a defined IP distance of 35 mm, 80 mm or 160 mm was created by choosing the appropriate lengths of component. The maximum fracture strength was determined using a four-point bending test. The fracture force of all three groups was similar (p = 0.498). There was a highly significant correlation between the cortical area and the fracture strength (r = 0.804, p <  0.001), whereas bone density showed no influence. This study suggests that the IP distance has little influence on fracture strength in IP femoral fractures: the thickness of the cortex seems to be the decisive factor. Cite this article: Bone Joint J 2014;96-B:1378–84


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 10 | Pages 1403 - 1408
1 Oct 2012
Hannemann PFW Göttgens KWA van Wely BJ Kolkman KA Werre AJ Poeze M Brink PRG

The use of pulsed electromagnetic fields (PEMF) to stimulate bone growth has been recommended as an alternative to the surgical treatment of ununited scaphoid fractures, but has never been examined in acute fractures. We hypothesised that the use of PEMF in acute scaphoid fractures would accelerate the time to union by 30% in a randomised, double-blind, placebo-controlled, multicentre trial. A total of 53 patients in three different medical centres with a unilateral undisplaced acute scaphoid fracture were randomly assigned to receive either treatment with PEMF (n = 24) or a placebo (n = 29). The clinical and radiological outcomes were assessed at four, six, nine, 12, 24 and 52 weeks. A log-rank analysis showed that neither time to clinical and radiological union nor the functional outcome differed significantly between the groups. The clinical assessment of union indicated that at six weeks tenderness in the anatomic snuffbox (p = 0.03) as well as tenderness on longitudinal compression of the scaphoid (p = 0.008) differed significantly in favour of the placebo group. We conclude that stimulation of bone growth by PEMF has no additional value in the conservative treatment of acute scaphoid fractures


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 3 | Pages 391 - 397
1 Mar 2012
Parker MJ Bowers TR Pryor GA

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


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 3 | Pages 406 - 412
1 Mar 2010
Leonardsson O Sernbo I Carlsson Å åkesson K Rogmark C

In a series of 450 patients over 70 years of age with displaced fractures of the femoral neck sustained between 1995 and 1997 treatment was randomised either to internal fixation or replacement. Depending on age and level of activity the latter was either a total hip replacement or a hemiarthroplasty. Patients who were confused or bed-ridden were excluded, as were those with rheumatoid arthritis. At ten years there were 99 failures (45.6%) after internal fixation compared with 17 (8.8%) after replacement. The rate of mortality was high at 75% at ten years, and was the same in both groups at all times. Patient-reported pain and function were similar in both groups at five and ten years. Those with successfully healed fractures had more hip pain and reduction of mobility at four months compared with patients with an uncomplicated replacement, and they never attained a better outcome than the latter patients regarding pain or function. Primary replacement gave reliable long-term results in patients with a displaced fracture of the femoral neck


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 116 - 122
1 Jan 2010
Parker MI Pryor G Gurusamy K

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


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 10 | Pages 1422 - 1428
1 Oct 2010
van den Bekerom MPJ Hilverdink EF Sierevelt IN Reuling EMBP Schnater JM Bonke H Goslings JC van Dijk CN Raaymakers ELFB

The aim of this study was to analyse the functional outcome after a displaced intracapsular fracture of the femoral neck in active patients aged over 70 years without osteoarthritis or rheumatoid arthritis of the hip, randomised to receive either a hemiarthroplasty or a total hip replacement (THR). We studied 252 patients of whom 47 (19%) were men, with a mean age of 81.1 years (70.2 to 95.6). They were randomly allocated to be treated with either a cemented hemiarthroplasty (137 patients) or cemented THR (115 patients). At one- and five-year follow-up no differences were observed in the modified Harris hip score, revision rate of the prosthesis, local and general complications, or mortality. The intra-operative blood loss was lower in the hemiarthroplasty group (7% > 500 ml) than in the THR group (26% > 500 ml) and the duration of surgery was longer in the THR group (28% > 1.5 hours versus 12% > 1.5 hours). There were no dislocations of any bipolar hemiarthroplasty and eight dislocations of a THR during follow-up. Because of a higher intra-operative blood loss (p < 0.001), an increased duration of the operation (p < 0.001) and a higher number of early and late dislocations (p = 0.002), we do not recommend THR as the treatment of choice in patients aged ≥ 70 years with a fracture of the femoral neck in the absence of advanced radiological osteoarthritis or rheumatoid arthritis of the hip


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


The Bone & Joint Journal
Vol. 95-B, Issue 1 | Pages 111 - 114
1 Jan 2013
Altay MA Ertürk C Altay N Öztürk IA Baykara I Sert C Isikan UE

We compared the intracompartmental pressures (ICPs) of open and closed tibial fractures with the same injury pattern in a rabbit model. In all, 20 six-month-old New Zealand White male rabbits were used. They were randomised into two equal groups of ten rabbits; an open fracture group (group 1) and a closed fracture group (group 2). Each anaesthetised rabbit was subjected to a standardised fracture of the proximal half of the right tibia using a custom-made device. In order to create a grade II open fracture in group 1, a 10 mm segment of fascia and periosteum was excised. The ICP in the anterior compartment was monitored at six-hourly intervals for 48 hours. Although there was a statistically significant difference in ICP values within each group (both p < 0.001), there was no significant difference between the groups for all measurements (all p ≥ 0.089). In addition, in both groups there was a statistically significant increase in ICP within the first 24 hours, whereas there was a statistically significant decrease within the second 24 hours (p < 0.001 for both groups). We conclude that open tibial fractures should be monitored for the development of acute compartment syndrome to the same extent as closed fractures. Cite this paper: Bone Joint J 2013;95-B:111–14


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 7 | Pages 956 - 960
1 Jul 2012
Kim T Ha Y Kang B Lee Y Koo K

This prospective multicentre study was undertaken to determine whether the timing of the post-operative administration of bisphosphonate affects fracture healing and the rate of complication following an intertrochanteric fracture. Between August 2008 and December 2009, 90 patients with an intertrochanteric fracture who underwent internal fixation were randomised to three groups according to the timing of the commencement of risedronate treatment after surgery: Group A (from one week after surgery), Group B (from one month after surgery), and Group C (from three months after surgery). The radiological time to fracture healing was assessed as the primary endpoint, and the incidence of complications, including excessive displacement or any complication requiring revision surgery, as the secondary endpoint. The mean time to fracture healing post-operatively in groups A, B and C was 10.7 weeks (. sd. 4.4), 12.9 weeks (. sd. 6.2) and 12.3 weeks (. sd. 7.1), respectively (p = 0.420). At 24 weeks after surgery, all fractures had united, except six that had a loss of fixation. Functional outcomes at one year after surgery according to the Koval classification (p = 0.948) and the incidence of complications (p = 0.386) were similar in the three groups. This study demonstrates that the timing of the post-operative administration of bisphosphonates does not appear to affect the rate of healing of an intertrochanteric fracture or the incidence of complications


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 1 | Pages 76 - 81
1 Jan 2005
Pajarinen J Lindahl J Michelsson O Savolainen V Hirvensalo E

We treated 108 patients with a pertrochanteric femoral fracture using either the dynamic hip screw or the proximal femoral nail in this prospective, randomised series. We compared walking ability before fracture, intra-operative variables and return to their residence. Patients treated with the proximal femoral nail (n = 42) had regained their pre-operative walking ability significantly (p = 0.04) more often by the four-month review than those treated with the dynamic hip screw (n = 41). Peri-operative or immediate post-operative measures of outcome did not differ between the groups, with the exception of operation time. The dynamic hip screw allowed a significantly greater compression of the fracture during the four-month follow-up, but consolidation of the fracture was comparable between the two groups. Two major losses of reduction were observed in each group, resulting in a total of four revision operations. Our results suggest that the use of the proximal femoral nail may allow a faster postoperative restoration of walking ability, when compared with the dynamic hip screw


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 6 | Pages 837 - 840
1 Jun 2005
Azzopardi T Ehrendorfer S Coulton T Abela M

We performed a prospective, randomised study on 57 patients older than 60 years of age with unstable, extra-articular fractures of the distal radius to compare the outcome of immobilisation in a cast alone with that using supplementary, percutaneous pinning. Patients treated by percutaneous wires had a statistically significant improvement in dorsal angulation (mean 7°), radial length (mean 3 mm) and radial inclination (mean 3 mm) at one year. However, there was no significant difference in functional outcome in terms of pain, range of movement, grip strength, activities of daily living and the SF-36 score except for an improved range of movement in ulnar deviation in the percutaneous wire group. One patient developed a pin-track infection which required removal of the wires at two weeks. We conclude that percutaneous pinning of unstable, extra-articular fractures of the distal radius provides only a marginal improvement in the radiological parameters compared with immobilisation in a cast alone. This does not correlate with an improved functional outcome in a low-demand, elderly population


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 11 | Pages 1488 - 1494
1 Nov 2007
Gorodetskyi IG Gorodnichenko AI Tursin PS Reshetnyak VK Uskov ON

We undertook a trial on 60 patients with AO 31A2 fractures of the hip who were randomised after stabilisation of the fracture into two equal groups, one of which received post-operative treatment using a non-invasive interactive neurostimulation device and the other with a sham device. All other aspects of their rehabilitation were the same. The treatment was continued for ten days after operation. Outcome measurements included the use of a visual analogue scale for pain, the brief pain inventory and Ketorolac for post-operative control of pain, and an overall assessment of outcome by the surgeon. There were significantly better results for the patients receiving treatment by active electrical stimulation (repeated measures analysis of variance, p < 0.001). The findings of this pilot trial justify a larger study to determine if these results are more generally applicable


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 4 | Pages 492 - 496
1 May 2002
Giannoudis PV Snowden S Matthews SJ Smye SW Smith RM

We have carried out a prospective, randomised trial to measure the rise of temperature during reaming of the tibia before intramedullary nailing. We studied 34 patients with a mean age of 35.1 years (18 to 63) and mean injury severity score of 10 (9 to 13). The patients were randomised into two groups: group 1 included 18 patients whose procedure was undertaken without a tourniquet and group 2, 16 patients in whom a tourniquet was used. The temperature in the bone was measured directly by two thermocouples inserted into the cortical bone near the isthmus of the tibial diaphysis. Reaming was carried out to at least 1.5 mm above the required diameter of the nail. Blood loss was assessed by recording the preoperative and postoperative haemoglobin (Hb) level. The minimum clinical follow-up was six months. In group 1 (no tourniquet), the mean Hb dropped 2.8 g/dl from 14.3 ± 1.02 g/dl to 11.5 ± 1.04 g/dl (p = 0.0001), whereas with the tourniquet, the mean decrease was 1.3 g/dl from 14 ± 1 g/dl to 12.7 ± 1.3 g/dl (p = 0.007). This difference was not statistically significant. The mean initial tibial temperature was 35.6°C (. sd. 0.6) and rose with reaming to levels between 36.3°C and 51.6°C. The highest temperatures were obtained with the largest reamers (11 and 12 mm, p = 0.0001) and the most rapid rise with the smallest diameters of medullary canal (8 or 9 mm). The rise of temperature was transient (20s). We were unable to identify any effect of the use of a tourniquet on the temperature achieved. Reamed intramedullary tibial nailing induces a transient elevation of temperature which is directly related to the amount of reaming


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 8 | Pages 1117 - 1122
1 Aug 2005
Fuchs S Heyse T Rudofsky G Gosheger G Chylarecki C

There is a high risk of venous thromboembolism when patients are immobilised following trauma. The combination of low-molecular-weight heparin (LMWH) with graduated compression stockings is frequently used in orthopaedic surgery to try and prevent this, but a relatively high incidence of thromboembolic events remains. Mechanical devices which perform continuous passive motion imitate contractions and increase the volume and velocity of venous flow. In this study 227 trauma patients were randomised to receive either treatment with the Arthroflow device and LMWH or only with the latter. The Arthroflow device passively extends and plantarflexes the feet. Patients were assessed initially by venous-occlusion plethysmography, compression ultrasonography and continuous wave Doppler, which were repeated weekly without knowledge of the category of randomisation. Those who showed evidence of deep-vein thrombosis underwent venography for confirmation. The incidence of deep-vein thrombosis was 25% in the LMWH group compared with 3.6% in those who had additional treatment with the Arthroflow device (p < 0.001). There were no substantial complications or problems of non-compliance with the Arthroflow device. Logistic regression analysis of the risk factors of deep-vein thrombosis showed high odds ratios for operation (4.1), immobilisation (4.3), older than 40 years of age (2.8) and obesity (2.2)


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 11 | Pages 1495 - 1498
1 Nov 2008
Shen J Tong P Qu H

This randomised study compared outcomes in patients with displaced fractures of the clavicle treated by open reduction and fixation by a reconstruction plate which was placed either superiorly or three-dimensionally. Between 2003 and 2006, 133 consecutive patients with a mean age of 44.2 years (18 to 60) with displaced midshaft fractures of the clavicle were allocated randomly to a three-dimensional (3D) (67 patients) or superior group (66). Outcome measures included the peri-operative outcome index, delayed union, revision surgery and symptoms beyond 16 weeks. CT was used to reconstruct an image of each affected clavicle and Photoshop 7.0 software employed to calculate the percentage of the clavicular cortical area in the sagittal plane. The patients were reviewed clinically and radiographically at four and 12 months after the operation. The superior plate group had a higher rate of delayed union and had more symptomatic patients than the 3D group (p < 0.05). The percentage comparisons of cortical bone area showed that cortical bone in the superior distal segment is thicker than in the inferior segment, it is also thicker in the anterior mid-section than in the posterior (p < 0.05). If fixation of midshaft fractures of the clavicle with a plate is indicated, a 3D reconstruction plate is better than one placed superiorly, because it is consistent with the stress distribution and shape of the clavicle


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 10 | Pages 1347 - 1350
1 Oct 2006
Karn NK Singh GK Kumar P Shrestha B Singh MP Gowda MJ

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 Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 1 | Pages 110 - 114
1 Jan 1996
Butt MS Krikler SJ Ali MS

We performed a prospective, randomised controlled trial of the operative versus non-operative treatment of 42 displaced fractures of the distal femur in elderly patients. Excellent or good results were achieved in 53% of the operated group and in 31% of the non-operated group. There were more complications in the latter, and the time to discharge was considerably longer


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 4 | Pages 580 - 583
1 Jul 1996
Court-Brown CM Will E Christie J McQueen MM

We performed a prospective, randomised study on 50 patients with Tscherne C1 tibial diaphyseal fractures comparing treatment with reamed and unreamed intramedullary nails. Our results show that reamed nailing is associated with a significantly lower time to union and a reduced requirement for a further operation. Unreamed nailing should not be used in the treatment of the common Tscherne C1 tibial fracture