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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 3 - 3
1 Sep 2012
Lee R Lee R Dvorak M Kwon B
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Introduction. While there is a desperate need for effective treatments for acute spinal cord injury (SCI), the clinical validation of novel therapeutic interventions is severely hampered by the need to recruit relatively large numbers of patients into clinical trials for sufficient statistical power. While a centre might annually admit 100 acute SCI patients, only a fraction may satisfy the basic inclusion criteria for an acute clinical trial, which typically requires patients of a certain injury severity (eg ASIA A), within a specific time window (eg. 12 hours from injury), and without other major injuries or conditions that would cloud the baseline neurologic assessment. This study was conducted to define that “fraction” of SCI patients that would theoretically satisfy standard inclusion criteria of an acute clinical trial. Methods. Using a local database, we reviewed patients admitted to our Level 1 trauma center with a complete (ASIA A) or an incomplete (ASIA B, C and D) acute SCI involving bony spinal levels between C0 and sacrum. All patients admitted over the 4 year period from 2005 to 2009 were reviewed. Demographic information and data about the patients' SCI and other injuries were reviewed. We then determined how many of the total number of SCI patients would be eligible for enrolment into a hypothetical acute clinical trial that required a valid baseline assessment of neurologic impairment, and an enrolment window of either 12 hours, 24 hours, or 48 hours. Results. 408 acute traumatic SCI patients were admitted over the 4 year period. 253 of 408 (62%) patients presented within 12 hours of injury, 60 (15%) between 12–24 hours, and 28 (7%) between 24–48 hours. 42% of patients were ASIA A, 13% B, 18% C and 27% D. The number of patients who presented with injuries or other conditions that would exclude them from enrolment was relatively high: 4% had penetrating injuries, 12% had illicit drug use, and 20% had either alcohol intoxication or head injuries which precluded a valid baseline neurologic examination. Conclusions. Out of a total of 408 patients admitted over 4 years, the number who would have been optimistically eligible for an acute neuroprotective trial was disappointingly small. Given that acute clinical trials are increasingly interested in cervical ASIA A patients (in whom segmental motor recovery can be assessed), the number of such patients who would actually be eligible for an acute intervention was surprisingly low. Given that additional inclusion/exclusion criteria would also be applicable in a real clinical trial, the true number of “eligible” or “recruitable” patients is conservatively even lower. This study is the first to quantify this challenging aspects of conducting acute SCI clinical trials, and provides valuable information for those planning such initiative


Bone & Joint Research
Vol. 2, Issue 3 | Pages 51 - 57
1 Mar 2013
Sullivan MP Torres SJ Mehta S Ahn J

Neurogenic heterotopic ossification (NHO) is a disorder of aberrant bone formation affecting one in five patients sustaining a spinal cord injury or traumatic brain injury. Ectopic bone forms around joints in characteristic patterns, causing pain and limiting movement especially around the hip and elbow. Clinical sequelae of neurogenic heterotopic ossification include urinary tract infection, pressure injuries, pneumonia and poor hygiene, making early diagnosis and treatment clinically compelling. However, diagnosis remains difficult with more investigation needed. Our pathophysiological understanding stems from mechanisms of basic bone formation enhanced by evidence of systemic influences from circulating humor factors and perhaps neurological ones. This increasing understanding guides our implementation of current prophylaxis and treatment including the use of non-steroidal anti-inflammatory drugs, bisphosphonates, radiation therapy and surgery and, importantly, should direct future, more effective ones


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 286 - 286
1 Sep 2012
Alani A Taylor G
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Background. A pedobarograph is a device that records pressures exerted by the foot on contact with the ground. Clinically most publications using pedobarography investigated diabetic foot pressures for prevention of ulcers, and assessing gait and sway. Only limited work was done on the effects of foot surgery on foot pressures. Any comparison between papers is hampered by the absence of available defined normal ranges of foot pressures. Aims of Study. The objective of the research project is to describe the foot pressures for 250 volunteers and to identify any trends and relationships of age, sex, body mass index (BMI), shoe & foot size and ethnic origin to foot pressures. The study is to provide a baseline upon which further comparative clinical research can be built. Materials and Methods. a sample size of 250 volunteers was determined after statistical advice. Ethics approval was sought. Recruitment was done after consent from Leicester Royal Infirmary and Leicester University. Volunteers with lower limb injury, diabetes, peripheral vascular disease or spinal cord injuries were excluded. Participants walked barefooted onto a (Takscan) matrix pressure mat. They walked at a speed they considered normal for themselves, as recommended by Taylor et al. We used the two step initiation protocol, invented by Myers-Rice et al to control the stride length, volunteers stood two steps away from the mat and hit the mat in their second step. Five steps per foot were collected for each patient and the average per foot area was calculated. The five steps method provided a coefficient of reliability of 0.94. Each foot was divided into 13 areas using the Tekscan software package. Data analysis was done using SPSS. Study participants’ characteristics (age, sex, foot size, height, weight and BMI) were summarised as a whole and by ethnic group, in tabular and graphical form. Histograms of foot pressure parameters (mean peak pressure at the medial and lateral heel, the mid foot, the head of each metatarsal and at each toe) were generated. The confidence interval was set to 95% and the level of significance to 0.05. Regression analysis testing was carried out to determine any significant relations between the variables. Coefficient of determination was reported for models including age, sex and ethnic origin, with and without adjustment for other body size measures. Results. Study population demographics, as well as BMI, height, weight and the average foot size were described. The average peak foot pressure for each foot area for each ethnic group was described and compared. Regression analysis of the variables has shown statistically significant associations between >70 years age group and low midfoot pressure, high BMI/weight and high midfoot pressure, big foot size and high midfoot pressure. The white western European group had the highest overall foot pressures


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 5 | Pages 637 - 641
1 May 2006
Akita S Wada E Kawai H

A total of 11 patients with combined traumatic injuries of the brachial plexus and spinal cord were reviewed retrospectively. Brachial plexus paralysis in such dual injuries tends to be diagnosed and treated late and the prognosis is usually poor. The associated injuries, which were all on the same side as the plexus lesion, were to the head (nine cases), shoulder girdle (five), thorax (nine) and upper limb (seven). These other injuries were responsible for the delayed diagnosis of brachial plexus paralysis and the poor prognosis was probably because of the delay in starting treatment and the severity of the associated injuries. When such injuries are detected in patients with spinal cord trauma, it is important to consider the possibility of involvement of the brachial plexus.


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 884 - 891
1 Jul 2016
Elliott DS Newman KJH Forward DP Hahn DM Ollivere B Kojima K Handley R Rossiter ND Wixted JJ Smith RM Moran CG

This article presents a unified clinical theory that links established facts about the physiology of bone and homeostasis, with those involved in the healing of fractures and the development of nonunion. The key to this theory is the concept that the tissue that forms in and around a fracture should be considered a specific functional entity. This ‘bone-healing unit’ produces a physiological response to its biological and mechanical environment, which leads to the normal healing of bone. This tissue responds to mechanical forces and functions according to Wolff’s law, Perren’s strain theory and Frost’s concept of the “mechanostat”. In response to the local mechanical environment, the bone-healing unit normally changes with time, producing different tissues that can tolerate various levels of strain. The normal result is the formation of bone that bridges the fracture – healing by callus. Nonunion occurs when the bone-healing unit fails either due to mechanical or biological problems or a combination of both. In clinical practice, the majority of nonunions are due to mechanical problems with instability, resulting in too much strain at the fracture site. In most nonunions, there is an intact bone-healing unit. We suggest that this maintains its biological potential to heal, but fails to function due to the mechanical conditions. The theory predicts the healing pattern of multifragmentary fractures and the observed morphological characteristics of different nonunions. It suggests that the majority of nonunions will heal if the correct mechanical environment is produced by surgery, without the need for biological adjuncts such as autologous bone graft.

Cite this article: Bone Joint J 2016;98-B:884–91.