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Bone & Joint Open
Vol. 3, Issue 3 | Pages 189 - 195
4 Mar 2022
Atwan Y Sprague S Slobogean GP Bzovsky S Jeray KJ Petrisor B Bhandari M Schemitsch E

Aims. To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. Methods. Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury. Results. After applying inverse probability treatment weighting to adjust for the influence of injury characteristics on type of dressing used, 1,322 participants were assessed. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.52-times higher in patients who received NPWT compared to those who received a standard wound dressing (95% confidence interval (CI) 1.84 to 11.12; p = 0.001). Overall, 1,040 participants were included in our HRQoL analysis, and those treated with NPWT had statistically significantly lower mean SF-12 PCS post-fracture (p < 0.001). These differences did not reach the minimally important difference for the SF-12 PCS. Conclusion. Our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management within 12 months post-fracture. Due to possible residual confounding with the worst cases being treated with NPWT, we are unable to determine if NPWT has a negative effect or is simply a marker of worse injuries or poor access to early soft-tissue coverage. Regardless, our results suggest that the use of this treatment requires further evaluation. Cite this article: Bone Jt Open 2022;3(3):189–195


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 912 - 917
1 Jul 2020
Tahir M Chaudhry EA Zimri FK Ahmed N Shaikh SA Khan S Choudry UK Aziz A Jamali AR

Aims. It has been generally accepted that open fractures require early skeletal stabilization and soft-tissue reconstruction. Traditionally, a standard gauze dressing was applied to open wounds. There has been a recent shift in this paradigm towards negative pressure wound therapy (NPWT). The aim of this study was to compare the clinical outcomes in patients with open tibial fractures receiving standard dressing versus NPWT. Methods. This multicentre randomized controlled trial was approved by the ethical review board of a public sector tertiary care institute. Wounds were graded using Gustilo-Anderson (GA) classification, and patients with GA-II to III-C were included in the study. To be eligible, the patient had to present within 72 hours of the injury. The primary outcome of the study was patient-reported Disability Rating Index (DRI) at 12 months. Secondary outcomes included quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates at 12 months. Logistic regression analysis and independent-samples t-test were applied for secondary outcomes. Analyses of primary and secondary outcomes were performed using SPSS v. 22.0.1 and p-values of < 0.05 were considered significant. Results. A total of 486 patients were randomized between January 2016 and December 2018. Overall 206 (49.04%) patients underwent NPWT, while 214 (50.95%) patients were allocated to the standard dressing group. There was no statistically significant difference in DRI at 12 months between NPWT and standard dressing groups (mean difference 0.5; 95% confidence interval (CI) -0.08 to 1.1; p = 0.581). Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781). The 30-day deep infection rate was slightly higher in the standard gauze dressing group. The non-union odds were also comparable (odds ratio (OR) 0.90, 95% CI 0.56 to 1.45; p = 0.685). Conclusion. Our study concludes that NPWT therapy does not confer benefit over standard dressing technique for open fractures. The DRI, SF-12 scores, wound infection, and nonunion rates were analogous in both study groups. We suggest surgeons continue to use cheaper and more readily available standard dressings. Cite this article: Bone Joint J 2020;102-B(7):912–917


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_8 | Pages 42 - 42
1 May 2018
Mazoochy H Vris A Brien J Heidari N
Full Access

Introduction. Segmental bone defect is a challenging problem. We report our experience of bone transport by hexapod external fixator in patients with segmental defects if the tibia. Method. We report herein 15 patients with segmental bone defect of tibia who completed their treatment protocol. All patients were treated had bone transport with Taylor Spatial Frame from 2012 to 2017. All were treated by the senior author NH. Parameters measured included age, sex, diabetes, smoking, diagnosis, method of fixation prior to treatment use of a free flap, bone defect size, frame-time, external fixation index. Results. Mean age at the time of frame application was 42.7 years. Mean follow-up after frame removal was 23.7 months. Three were diabetic, one smoked and one quit smoking during treatment. Seven had Gustilo-Anderson 3B (47%) and 5 Gustilo-Anderson 3A (33%) open fractures. Three (20%) had closed fractures. Nine (60%) had internal fixation with plate in eight and IM nail in one. Ten patients (67%) had soft tissue defect that required a free flap in seven, local flap in two and skin graft in one. Mean transport was 62 mm. Mean external fixator time and latency were 350.1 and 12 days, respectively. Mean External fixator, distraction and maturation indices were 2.1, 0.52 and 1.43 month per centimeter, respectively. Ten Extra- procedures were required in 7 patients. There were no docking site procedures, non-union of regenerate, adjunctive stabilization after frame removal, recurrence of bone infection and recurrence of deformity. Conclusions. Segmental resection and transport by TSF is an effective method to achieve length, alignment and eradicate infection. Although our cohort had longer external fixator indices than similar studies, the complication rate was low


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 11 | Pages 1563 - 1567
1 Nov 2010
Parmaksizoglu F Koprulu AS Unal MB Cansu E

We present the results of 13 patients who suffered severe injuries to the lower leg. Five sustained a traumatic amputation and eight a Gustilo-Anderson type IIIC open fracture. All were treated with debridement, acute shortening and stabilisation of the fracture and vascular reconstruction. Further treatment involved restoration of tibial length by callus distraction through the distal or proximal metaphysis, which was commenced soon after the soft tissues had healed (n = 8) or delayed until union of the fracture (n = 5). All patients were male with a mean age of 28.4 years (17 to 44), and had sustained injury to the leg only. Chen grade II functional status was achieved in all patients. Although the number of patients treated with each strategy was limited, there was no obvious disadvantage in the early lengthening programme, which was completed more quickly


The Bone & Joint Journal
Vol. 96-B, Issue 3 | Pages 379 - 384
1 Mar 2014
Hull PD Johnson SC Stephen DJG Kreder HJ Jenkinson RJ

This study explores the relationship between delay to surgical debridement and deep infection in a series of 364 consecutive patients with 459 open fractures treated at an academic level one trauma hospital in North America. . The mean delay to debridement for all fractures was 10.6 hours (0.6 to 111.5). There were 46 deep infections (10%). There were no infections among the 55 Gustilo-Anderson grade I open fractures. Among the grade II and III injuries, a statistically significant increase in the rate of deep infection was found for each hour of delay (OR = 1.033: 95% CI 1.01 to 1.057). This relationship shows a linear increase of 3% per hour of delay. No distinct time cut-off points were identified. Deep infection was also associated with tibial fractures (OR = 2.44: 95% CI 1.26 to 4.73), a higher Gustilo-Anderson grade (OR = 1.99: 95% CI 1.004 to 3.954), and contamination of the fracture (OR = 3.12: 95% CI 1.36 to 7.36). These individual effects are additive, which suggests that delayed debridement will have a clinically significant detrimental effect on more severe open fractures. Delayed treatment appeared safe for grade 1 open fractures. However, when the negative prognostic factors of tibial site, high grade of fracture and/or contamination are present we recommend more urgent operative debridement. . Cite this article: Bone Joint J 2014;96-B:379–84


Bone & Joint Open
Vol. 5, Issue 8 | Pages 621 - 627
1 Aug 2024
Walter N Loew T Hinterberger T Alt V Rupp M

Aims

Fracture-related infections (FRIs) are a devastating complication of fracture management. However, the impact of FRIs on mental health remains understudied. The aim of this study was a longitudinal evaluation of patients’ psychological state, and expectations for recovery comparing patients with recurrent FRI to those with primary FRI.

Methods

A prospective longitudinal study was conducted at a level 1 trauma centre from January 2020 to December 2022. In total, 56 patients treated for FRI were enrolled. The ICD-10 symptom rating (ISR) and an expectation questionnaire were assessed at five timepoints: preoperatively, one month postoperatively, and at three, six, and 12 months.


The Bone & Joint Journal
Vol. 97-B, Issue 8 | Pages 1118 - 1125
1 Aug 2015
Kwasnicki RM Hettiaratchy S Okogbaa J Lo B Yang G Darzi A

In this study we quantified and characterised the return of functional mobility following open tibial fracture using the Hamlyn Mobility Score. A total of 20 patients who had undergone reconstruction following this fracture were reviewed at three-month intervals for one year. An ear-worn movement sensor was used to assess their mobility and gait. The Hamlyn Mobility Score and its constituent kinematic features were calculated longitudinally, allowing analysis of mobility during recovery and between patients with varying grades of fracture. The mean score improved throughout the study period. Patients with more severe fractures recovered at a slower rate; those with a grade I Gustilo-Anderson fracture completing most of their recovery within three months, those with a grade II fracture within six months and those with a grade III fracture within nine months. . Analysis of gait showed that the quality of walking continued to improve up to 12 months post-operatively, whereas the capacity to walk, as measured by the six-minute walking test, plateaued after six months. . Late complications occurred in two patients, in whom the trajectory of recovery deviated by > 0.5 standard deviations below that of the remaining patients. This is the first objective, longitudinal assessment of functional recovery in patients with an open tibial fracture, providing some clarification of the differences in prognosis and recovery associated with different grades of fracture. Cite this article: Bone Joint J 2015; 97-B:1118–25


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_5 | Pages 18 - 18
1 May 2015
Chan Y Selvaratnam V James L Nayagam S
Full Access

Background:. The outcomes of open tibial fractures in a paediatric population are reported. Methods:. A retrospective analysis of consecutive cases, classified by the Gustilo-Anderson system, over the last 8 years was undertaken. The outcomes recorded were time to union, non-union, infection rates and re-operation rates. Results:. There were 60 open tibial fractures; 8.3% grade 1, 10.0% grade 2, 38.3% grade 3a, 36.7% grade 3b, and 6.7% grade 3c. There were 19 females and 41 males with a median age of 12 years. The time to first debridement was within 24 hours in 95% of patients. External fixation was used definitively in 62.7% with internal fixation next (13.6%). The mean time to union was 4 months. There was a 10.0% non-union and a 1.7% deep infection rate. Thirty percent needed re-operation: soft tissue procedures (6.7%); malaignment (5%); delayed union (5%) and infection (3.3%). All fractures united at final follow-up. There was no statistical difference between the methods of fixation on non-union rate. Conclusion:. Open tibial fractures in the paediatric population demonstrate a high union and low deep infection rate as compared to the adults. The findings support the recommendations from current BOA/BAPRAS standards on the management of these injuries


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 736 - 746
1 Jun 2022
Shah A Judge A Griffin XL

Aims

This study estimated trends in incidence of open fractures and the adherence to clinical standards for open fracture care in England.

Methods

Longitudinal data collected by the Trauma Audit and Research Network were used to identify 38,347 patients with open fractures, and a subgroup of 12,170 with severe open fractures of the tibia, between 2008 and 2019 in England. Incidence rates per 100,000 person-years and 95% confidence intervals were calculated. Clinical care was compared with the British Orthopaedic Association Standards for Trauma and National Major Trauma Centre audit standards.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_4 | Pages 8 - 8
1 May 2015
Tsang S Mills L Frantzias J Baren J Keating J Simpson A
Full Access

The aim of this study was to identify risk factors for failure of exchange nailing for femoral diaphyseal fracture non-unions. The study cohort comprised 40 patients with femoral diaphyseal non-unions treated by exchange nailing. The main outcome measures were union, number of secondary fixation procedures required to achieve union and time to union. Univariate analysis and multiple regression were used to identify risk factors for failure to achieve union. The mean age of the patients at exchange nail surgery was 37 years. The median time to exchange nailing from primary fixation was 8.4 months. Multiple causes for non-union were found in 14 (35.0%) cases, with infection present in 12 (30.0%) patients. Further exchange procedures were required in nine (22.5%) cases, one patient (2.5%) required the use of another fixation modality, to achieve union. Union was ultimately achieved in 35 (94.5%) patients. The median time to union was 9.4 months after the exchange nail procedure. Univariate analysis confirmed that cigarette smoking and infection were predictive of failure (p<0.05). Multi-regression analysis found that Gustilo-Anderson grade, presence of dead bone or a gap and infection were predictive of exchange nail failure (p <0.05). Exchange nailing is an effective treatment for aseptic femoral diaphyseal fracture non-union. Patients with infection required more than one procedure. Smoking, infection and the presence of dead-bone or a gap at the fracture site were associated with an increased risk of further fixation surgery


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 994 - 999
1 Sep 2024
El-Khaldi I Gude MH Gundtoft PH Viberg B

Aims

Pneumatic tourniquets are often used during the surgical treatment of unstable traumatic ankle fractures. The aim of this study was to assess the risk of reoperation after open reduction and internal fixation of ankle fractures with and without the use of pneumatic tourniquets.

Methods

This was a population-based cohort study using data from the Danish Fracture Database with a follow-up period of 24 months. Data were linked to the Danish National Patient Registry to ensure complete information regarding reoperations due to complications, which were divided into major and minor. The relative risk of reoperations for the tourniquet group compared with the non-tourniquet group was estimated using Cox proportional hazards modelling.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 746 - 752
1 Oct 2022
Hadfield JN Omogbehin TS Brookes C Walker R Trompeter A Bretherton CP Gray A Eardley WGP

Aims

Understanding of open fracture management is skewed due to reliance on small-number lower limb, specialist unit reports and large, unfocused registry data collections. To address this, we carried out the Open Fracture Patient Evaluation Nationwide (OPEN) study, and report the demographic details and the initial steps of care for patients admitted with open fractures in the UK.

Methods

Any patient admitted to hospital with an open fracture between 1 June 2021 and 30 September 2021 was included, excluding phalanges and isolated hand injuries. Institutional information governance approval was obtained at the lead site and all data entered using Research Electronic Data Capture. Demographic details, injury, fracture classification, and patient dispersal were detailed.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_9 | Pages 11 - 11
1 May 2014
Wood A Robertson G Macleod K Heil K Keenan A Court-Brown C
Full Access

Open fractures are uncommon in the UK sporting population, however because of their morbidity then are a significant patient group. Currently there is very little in the literature describing the epidemiology of open fracture in sport. We describe the epidemiology of sport related open fractures from one centre's adult patient population. Retrospective analysis of a prospectively collected database recording all sport related open fracture s over a 15 year period in a standard population. Over the 15 year period, there were 85 fractures in 84 patients. The mean age was 29.2 years (range 15–67). 70 (83%) were male and fourteen female (17%). The six most common sports were football (n=19, 22%), rugby (n=9, 11%), cycling (n=8, 9%), hockey (n=8, 9%); horse riding (n=6, 7%) and skiing (n=6, 7%). The top five anatomical locations were fingers phalanges, 35%; tibia-fibula 23%; foreman 14%; ankle 11% and metacarpals 5%. The mean injury severity score was 7.02. Forty five patients were grade 1; 28 patients were grade 2; 8 patients were grade 3a; and 4 were grade 3b according to the Gustilo-Anderson classification system. Seven patients (8%) required plastic surgical intervention for the treatment of these fractures. The types of flaps used were split skin graft (n=4), fasciocutaneous flaps (n=2); and adipofascial flap (n=1). We looked at the epidemiology open fractures secondary to sport in one centre over a 15 year period. Football was the most common sport (22%) and within football, the most common site was the tibia and fibula. In contrast, within the cohort a whole the majority of fractures were upper limb, with the hand being the most common site. Whilst not common in sport, when they are sustained they are frequently occur on muddy sport fields or forest tracks and must be treated appropriately. A good understanding of the range and variety of injuries commonly sustained in different sports is important for clinicians and sports therapists


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 1 | Pages 80 - 88
1 Jan 2007
El-Rosasy MA

We have managed 21 patients with a fracture of the tibia complicated by bone and soft-tissue loss as a result of an open fracture in 10, or following debridement of an infected nonunion in 11, by resection of all the devitalised tissues, acute limb shortening to close the defect, application of an external fixator and metaphyseal osteotomy for re-lengthening. The mean bone loss was 4.7 cm (3 to 11). The mean age of the patients was 28.8 years (12 to 54) and the mean follow-up was 34.8 months (24 to 75). All the fractures united with a well-aligned limb. The mean duration of treatment for the ten grade-III A+B open fractures (according to the Gustilo-Anderson classification) was 5.7 months (4.5 to 8) and for the nonunions, 7.6 months (5.5 to 12.5). Complications included one refracture, one transient palsy of the peroneal nerve and one equinus contracture of 10°


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1055 - 1062
1 Jun 2021
Johal H Axelrod D Sprague S Petrisor B Jeray KJ Heels-Ansdell D Bzovsky S Bhandari M

Aims

Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and debridement (I&D) and the development of subsequent deep infection has not been established in the literature. Traditionally, I&D of an open fracture has been recommended within six hours of injury based on animal studies from the 1970s, however the clinical basis for this remains unclear. Using data from a multicentre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound I&D (within six hours of injury vs beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open limb fractures requiring surgical treatment.

Methods

To adjust for the influence of patient and injury characteristics on the timing of I&D, a propensity score was developed from the dataset. Propensity-adjusted regression allowed for a matched cohort analysis within the study population to determine if early irrigation put patients independently at risk for reoperation, while controlling for confounding factors. Results were reported as odds ratios (ORs), 95% confidence intervals (CIs), and p-values. All analyses were conducted using STATA 14.


Bone & Joint Open
Vol. 2, Issue 10 | Pages 825 - 833
8 Oct 2021
Dailey HL Schwarzenberg P Webb, III EB Boran SAM Guerin S Harty JA

Aims

The study objective was to prospectively assess clinical outcomes for a pilot cohort of tibial shaft fractures treated with a new tibial nailing system that produces controlled axial interfragmentary micromotion. The hypothesis was that axial micromotion enhances fracture healing compared to static interlocking.

Methods

Patients were treated in a single level I trauma centre over a 2.5-year period. Group allocation was not randomized; both the micromotion nail and standard-of-care static locking nails (control group) were commercially available and selected at the discretion of the treating surgeons. Injury risk levels were quantified using the Nonunion Risk Determination (NURD) score. Radiological healing was assessed until 24 weeks or clinical union. Low-dose CT scans were acquired at 12 weeks and virtual mechanical testing was performed to objectively assess structural bone healing.


Bone & Joint Open
Vol. 1, Issue 8 | Pages 481 - 487
11 Aug 2020
Garner MR Warner SJ Heiner JA Kim YT Agel J

Aims

To compare results of institutional preferences with regard to treatment of soft tissues in the setting of open tibial shaft fractures.

Methods

We present a retrospective review of open tibial shaft fractures at two high-volume level 1 trauma centres with differing practices with regard to the acute management of soft tissues. Site 1 attempts acute primary closure, while site 2 prefers delayed closure/coverage. Comparisons include percentage of primary closure, number of surgical procedures until definitive closure, percentage requiring soft tissue coverage, and percentage of 90-day wound complication.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 548 - 548
1 Sep 2012
Purghel F Badea R Jemna C Ciuvic R Ivan A
Full Access

AIMS. Pure tibial plafond traumatic pathology (excluding trimalleolar fractures) is rare but troublesome, considering the surgical challenges and the long term disability perspective. Treatment involves a wide variety of implants and techniques, and the procedures choice and timing is highly dictated by the soft tissue damage. We designed this study to assess the status of our patients operated with internal, external or combined procedures. METHODS. In a retrospective study, between July 2008 and July 2010 we reviewed 24 patients with available follow-up data. We reviewed the pre- and post-operative imaging available and the immediate follow-up data. A form is currently mailed to the patients to self-evaluate the general physical, mental and employment status, and also the affected limb, using general approved questionnaires. Data from this form is still in process. RESULTS. In this clinic we recorded 24 patients with tibial plafond fractures (17 male, 7 female, 2.43 sex ratio), with ages between 18 and 82 years (average 46.5, median 39 years). According to AO/OTA classification, we noted 8 type A (2 A1, 3 A2, 3 A3) extra-articular tibial fractures, 9 type B (4 B1, 4 B2, 1 B3) intra-articular pilon fractures and 7 type C (3 C1, 1 C2, 3 C3) both epi- and metaphyseal tibial fractures, usually with peroneus fractures at various levels. 10 of these fractures were open, from them 3 type IIIA and 2 IIIB Gustilo-Anderson, and 3 of the patients were politrauma (1 L1 lumbar fracture and distal radius fracture, 1 cranio-cerebral trauma and type I open distal radius fracture and 1 cranio-cerebral trauma). We performed a large array of surgical procedures, usually in emergency, based mainly on the local soft tissue status and both the age and recovery needs of the patient. In old debilitated patients we preferred to use minimal internal osteosynthesis, usually applying a supplementary external fixator or cast. In young active patients we used MIPO techniques in tibial fractures, both with regular or locking-screw plates, repairing also the peroneus in order to preserve the limb length in diaphyseal fractures, and to reconstruct the ankle in lateral malleolus fractures. In cases with severe soft tissue impairment we delayed the definitive osteosynthesis using an external fixator. The short term outcome was good, noting only one septic nonunion, which healed with the appropriate treatment, one calcaneus pin track infection and one deterioration of the external fixator in an alcoholic patient. Data for the mid-term outcome is still under evaluation. CONCLUSIONS. Choosing the appropriate procedure is vital for the outcome. Timing is important, especially in high energy trauma, when the proper surgery performed in emergency allowed us to overcome most of the possible complications. Short term results are encouraging, and the mid-term results will let us know if our attitude was correct


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 17 - 25
1 Jan 2020
Trickett RW Mudge E Price P Pallister I

Aims

The aim of this study was to develop a psychometrically sound measure of recovery for use in patients who have suffered an open tibial fracture.

Methods

An initial pool of 109 items was generated from previous qualitative data relating to recovery following an open tibial fracture. These items were field tested in a cohort of patients recovering from an open tibial fracture. They were asked to comment on the content of the items and structure of the scale. Reduction in the number of items led to a refined scale tested in a larger cohort of patients. Principal components analysis permitted further reduction and the development of a definitive scale. Internal consistency, test-retest reliability, and responsiveness were assessed for the retained items.


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 D3 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.