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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.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 29 - 30
1 Mar 2005
Phadke P Trenholm A Bosse M Sims S Kellam J
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Open long bone fractures have been considered orthopaedic emergencies requiring immediate irrigation, debridement and stabilization. Concomitant traumatic brain injuries may preclude the immediate operative treatment of open fractures. The purpose of this study was to review patients with open tibial diaphyseal fractures whose operative tibial fracture management was delayed because of a concomitant traumatic brain injury to determine if there is an increased rate of infection or non-union.

After obtaining IRB approval, the trauma registry was scanned for patients who sustained both traumatic brain injury with an Abbreviated Injury Scale (AIS) equal to two or greater and an open tibial diaphyseal fracture. From January 1, 1996 to June 1, 2001, 28 patients with 31 open tibial shaft fractures were identified (Grade I=1, II=6, IIIA=17, IIIB= 7). There were 24 males and 4 females with an average age of 35 years (range 13–69 years of age). The mechanism of injury was motor vehicle collision or pedestrian versus motor vehicle accident for all patients. The mean time to operative irrigation, debridement, and stabilization was 11 hours (range 2–152 hours). Thirteen patients underwent operative orthopaedic treatment within 8 hours (mean 4.4 ± 1.3 hours), and 15 patients underwent delayed debridement (mean 35 ± 35 hours). Twenty fractures were stabilized with intramedullary nailing, 9 fractures were stabilized with external fixation, one fracture was stabilized with a compression plate, and one fracture treated in a cast. A review of clinic records and telephone follow-up interviews was used to determine the rates of infection or non-union. Infection was defined as a positive deep surgical culture for bacteria upon repeat irrigation and debridement. Non-union was defined as any clinically and radiographically unhealed fracture requiring further operative procedures.

The average length of follow up was 2.9 years (range 1 month to 6.5 years). Of the 31 open tibial diaphyseal fractures, four fractures (12.9%) were complicated by infection and four fractures (12.9%) went on to non-union. There was no statistical difference in the rates of infection or non-union in patients who underwent irrigation and debridement within eight hours and those that underwent irrigation and debridement after eight hours from the time of initial presentation (odds ratio=1.02, p=0.15). Furthermore there was no correlation between the ultimate presence of infection/non-union and grade of open tibial shaft fracture, initial method of fixation, timing of wound closure (immediate, delayed primary closure, or split-thickness skin graft or flap), severity of overall injury, and epidemiological characteristics.

In this subset of 28 patients with 31 open tibial shaft fractures and concomitant traumatic brain injuries, there was no difference in the incidence of infection or non-union in patients who underwent operative treatment within eight hours of admission to hospital and those who underwent operative treatment after eight hours. The results of this study should be considered in the prioritization of care for the multiply injured trauma patient.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 31 - 31
1 Mar 2005
Karunakar M Bosse M Hall J Sims S Le T Kellam J Goulet J Freeborn M
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This study was designed to prospectively evaluate the efficacy of indomethacin as prophylaxis for heterotopic ossification (HO) after operatively treated acetabular fractures.

An IRB approved, prospective double blind placebo controlled clinical trial was performed at two level I trauma centres to evaluate the efficacy of indomethacin as prophylaxis for heterotopic ossification after the operative treatment of acetabular fractures. Between January 1, 1999 and May 31, 2003, two hundred and thirty-two patients with acetabular fractures were treated operatively through a posterior approach. Patients with the following conditions were excluded from study participation: age < 18, spinal cord injury, ankylosing spondylitis, burns, gastrointestinal bleed, Glasgow coma scale < 12, cerebrovascular accident, pregnancy and use of other non-steroidal anti-inflammatory drugs. One hundred and fifty-seven eligible patients were identified and one hundred and twenty-five patients were enrolled in the clinical trial. One hundred and seven patients have sufficient follow up to be included in data analysis. All patients underwent operative stabilization of their ace-tabular fractures by either a combined anterior and posterior approach or an isolated posterior Kocher-Lan-genbock approach. After fixation and prior to wound closure, any necrotic gluteus minimus muscle was debrided to viable muscle. Sixty-one patients were randomized to the placebo group and forty-six patients to the indomethacin treatment group. Indomethacin 75 mg SR and the placebo were administered to the patients by the investigational drug pharmacy in a blinded fashion. The medication was taken once daily for six weeks. Patient compliance was measured by obtaining indomethacin serum levels at the first postoperative visit (2 weeks). The extent of HO was evaluated on plain radiographs (AP and Judet) at three months postoperatively. The radiographs were scored for the presence of HO using the Brooker classification as modified by Moed. The data were analyzed two ways: 1) by excluding patients with protocol deviations and 2) by using an intent-to-treat model, where all enrolled subjects with 3 month Brooker scores were included in the analysis, regardless of whether they withdrew or were dropped from the study for clinical reasons. The sample size was estimated to produce a statistical power of 80% to detect a difference of 15% between the two treatment groups with alpha = .05.

There were no significant differences with regards to age, sex, body mass index (BMI), ISS (injury severity score) and complications between the two treatment groups. The overall incidence of HO (Brooker I-IV) was 52.8% and the overall incidence of significant HO (Brooker III/IV) was 19.6%. There were four patients with Brooker IV HO. There was no significant difference between the treatment groups in the incidence of HO according to Brooker class (p=0.23). Significant HO (Brooker grades III-IV) occurred in 8 cases (17%) in the indomethacin group and 13 cases (21%) in the placebo group. There was no significant difference in the presence of moderate to severe HO (Brooker III/IV) between the two treatment groups (Fisher’s exact test p=0.81). Eighty-two of one hundred and seven patients enrolled completed the protocol. Twenty-five patients did not complete the treatment protocol for the following reasons: stopped medication due to side effects, did not receive medication at discharge, lost medication, or medication stopped by another physician who did not understand the purpose of the study. Nine patients (8.4%) did not receive the full medication course, sixteen patients (15%) were dropped or withdrew from the study for adverse events or gastrointestinal symptoms. Twelve patients dropped or withdrew from the indomethacin group and three from the placebo group. Forty percent of patients in the indomethacin group had non-detectable serum levels at two weeks. Complications identified in the indomethacin treatment group included deep venous thrombosis (5), wound infection (2), nonunion (1), gastrointestinal bleed (1) and perforated ulcer (1). Complications identified in the placebo group included deep venous thrombosis (6) and wound infection (2).

In this prospective randomized study, a placebo provided as effective prophylaxis against the development of heterotopic ossification as indomethacin. More patients withdrew from the indomethacin group for gastrointestinal side effects or adverse events than in the placebo group. Patient compliance with indomethacin was poor with 40% of patients having no detectable indomethacin serum level. Serious gastrointestinal complications (gastrointestinal bleed and perforated ulcer) occurred in two patients treated with indomethacin.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 267 - 267
1 Nov 2002
Vincent A Sims S Kellam J Bosse M Peindl R Zura R
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Introduction: Unstable, extra-articular, proximal, tibia fractures are difficult clinical problems often complicated by mal-alignment and soft-tissue breakdown.

Aim: To evaluate the biomechanical properties of a traditional double plating (DP) technique, the Less Invasive Stabilization System (LISS) and hybrid external fixation. Secondarily, the clinical outcomes of an initial series of 20 fractures treated with the LISS system were to be evaluated.

Methods: The axial stiffness and biaxial tilt (varus/valgus and anterior/posterior) of the three systems were tested. Five synthetic tibiae per system were loaded in sequence under the following conditions of instability:

1)Intact.

2)1 cm medial wedge osteotomy (proximal metaphysis).

3)1 cm gap osteotomy.

Twenty proximal tibial fractures treated with the LISS system were reviewed to assess union rates, complications, knee motion and secondary procedures.

Results: There were no significant differences between the different systems when they were used on the intact specimens. The DP system was significantly stiffer axially and in varus tilt than the LISS and the hybrid systems for the wedge osteotomy for all loads. The LISS was significantly stiffer in varus tilt than the hybrid with the wedge at maximal loading. With the gap osteotomy, all three systems were significantly different from each other in both stiffness aspects (DP> LISS> hybrid). The hybrid exhibited axial gap closure at approximately one third of the force of the other systems. No implant failed or exhibited plastic deformation. In the clinical review all fractures united and only three required bone grafting. No fixation failed but there were three deep infections. Over 80% of the cases had knee motion of 90 degrees or better.

Conclusions: The DP was significantly stiffer than both the LISS and the hybrid system for axial displacement and varus tilt at comparable loads for the wedge and gap models. The LISS was significantly stiffer than the hybrid in the completely unstable gap model. The tibial LISS system gave encouraging initial clinical results.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 274 - 274
1 Nov 2002
Vincent A Kellam J Bosse M Sims S
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Introduction: Complex acetabular fractures often require an extensile exposure to visualise the fracture adequately. Such extensile exposures have been associated with increased morbidity. Simultaneous iliofemoral and Kocher-Langenbeck approaches offer an alternative to such exposures and do not involve sectioning of the abductor tendons or a trochanteric osteotomy. We have used simultaneous anterior and posterior exposures for complex fractures in which the transverse component is transtectal and for selected both-column fractures. This study reports on the technique and reviews 51 cases performed between 1990 and 1998.

Methods: Combined anterior and posterior surgical approaches were used in 51 of 397 acetabular fracture between 1990 and 1998. A retrospective review of the case notes of all 51 patients was performed and operative times, blood loss and complications were recorded. Pre-operative, post-operative and 12-month follow-up radiographs were assessed for fracture classification, adequacy of reduction and the development of heterotopic ossification. The presence of avascular necrosis and post-traumatic osteoarthritis were also noted.

Results: The average duration of surgery was 4 hours and 40 minutes and the average blood loss was 1735ml. A reduction within 1mm of the anatomic position was achieved in 71% of cases and within 3mm of the anatomic position in 92% of cases. There were two deep infections and two post-operative sciatic nerve palsies. There were two patients who developed Brooker grade IV heterotopic ossification.

Conclusions: Planned simultaneous iliofemoral and Kocher-Langenbeck exposures were performed with operation time, blood loss, fracture reduction and complications comparable with or better than other reported series using extensile exposures. We consider this approach a useful alternative particularly for complex fracture patterns of the acetabulum, which involve a displaced transtectal transverse component.