Clinical and Radiological Outcomes After Surgical Treatment of Lower Limb Fractures in Patients With Spinal Cord Injury.

STUDY DESIGN: Retrospective observational study. OBJECTIVES: To analyze the clinical and radiological outcomes of lower limb fractures following surgical treatment in patients with chronic spinal cord injury (SCI). METHODS: Between January 2003 and December 2015, 102 chronic SCI patients with a lower limb fracture were surgically treated at our hospital. A total of 58 patients met the inclusion criteria and were recruited for final analysis. Patients with 2-stage procedure or incomplete clinical records with lost-to-follow-up were excluded from the study. Patients were divided into 2 groups (group 1= internal fixation; group 2 = external fixation). Primary outcome measures were to identify the number of nonunions via Kaplan-Meier analysis and the time to bone consolidation. The diagnosis of a pseudarthrosis was made after more than 180 days of consolidation time. Considering the Kaplan-Meier analysis, pseudarthrosis was interpreted as treatment failure. Secondary outcome measure was to evaluate the complication rate with special focus on heterotopic ossification. RESULTS: A total of 58 chronic SCI patients with closed bone fractures were included in this study. Fifty-two fractures (88%) were simple and 7 (12%) were complex (type C) fractures according to AO classification. The majority of patients (34 cases, 59%) developed femur fractures followed by 24 tibial fractures (41%). Seventeen patients received an external (29%) and 41 an internal fixation (71%). Bone consolidation was reported in 31 patients (53%) with a mean time interval of bone consolidation after 97 days (range from 45 to 160 days; SD = 30). The reported nonunion (pseudarthrosis) rate was 47%. Comparing the internal group (n = 15 patients) versus the external group (n = 14), we could not find any significant difference (P = .939) concerning the bone consolidation time. The Kaplan-Meier analysis showed a 75% cumulative survivorship at 120 days (internal group) versus 111 days (external group). Most common postoperative complications occurred in the internal fixation group with Wound infections being predominantly observed (10%), followed by heterotopic ossifications (8%). CONCLUSIONS: Our results show that surgical treatment of lower limb fractures in chronic SCI patients is a challenging treatment with a high pseudarthrosis rate in both groups. The complication rate seems to be lower in the patients treated with external fixation. As a clinical recommendation, longer implants should be used for a stable osteosynthesis since SCI patients seem to have a higher load on the osteosynthesis material due to missing sensomotoric feedback.

Similar Adenoma Detection Rates in Colonoscopic Procedures of Patients with Spinal Cord Injury Compared to Controls.

BACKGROUND: Cancer is a major cause of death in patients with spinal cord injury (SCI). Preventive strategies, such as colonoscopy, deal with higher burdens that may lead to lower quality. AIMS: The primary objective was to evaluate the adenoma detection rate. Secondary objectives were to investigate other quality indicators regarding bowel preparation, sedation, and endoscopy. METHODS: Consecutive SCI patients who had undergone colonoscopy from 2003 to 2014 were assigned to a control group matched for age, gender, and year of procedure and reviewed retrospectively. RESULTS: Bowel preparation lasted longer (3.6 ± 1.5 vs. 1.2 ± 0.6 days, p = 0.001), achieved unsatisfactory cleansing results more often (23.7 vs. 3.6%) and caused more adverse events in 236 SCI compared to 414 control patients. Colonoscopy needed a longer time (36.9 vs. 25.0 min) and remained incomplete more often (24.6 vs. 4.6%), resulting in more re-colonoscopies (14.8 vs. 4.3%). Endoscopy- and sedation-related adverse events were equal. However, neither overall nor size-dependent polyp (30.9 vs. 34.8%), adenoma (21.2 vs. 21.0%), advanced adenoma (6.8 vs. 7.2%), or cancer (1.7 vs. 2.0%) detection rates differed. CONCLUSION: Despite intensified protocols, bowel preparation shows inferior results in SCI patients; colonoscopy needs more effort to succeed but achieves a comparable quality.

Cervical Spinal Cord Injury Shows Markedly Lower than Predicted Mortality (>72 Hours After Multiple Trauma) From Sepsis and Multiple Organ Failure.

BACKGROUND: Sepsis and multiple organ failure (MOF) remain one of the main causes of death after multiple trauma. Trauma- and infection-associated immune reactions play an important role in the pathomechanism of MOF, but the exact pathways remain unknown. Spinal cord injury (SCI) may lead to an altered immune response, and some studies suggest a prognostic advantage for such patients having sepsis or multiple trauma. Yet these findings need to be evaluated in larger cohorts of trauma patients. METHODS: Retrospective, multicenter study, using the data of the TraumaRegister DGU. Patients with and without SCI surviving the initial first 72 hours after trauma were matched according to injury pattern and age. Comparative analysis considered morbidity (sepsis, MOF) and hospital mortality. RESULTS: The study population included 800 matched pairs. As intended by the matching process, patients with cervical SCI had an otherwise comparable injury pattern but a higher severity of trauma (mean Injury Severity Score: 36 vs 29, mean number of diagnosis: 5.6 vs 4.4). They had a higher rate of sepsis (15.9% vs 10.9%, P = .005) and MOF (35.9% vs 24.1%, P < .001) while mortality revealed no significant difference (9.5% vs 9.9%, P = .866). CONCLUSIONS: Cervical SCI leads to an increased rate of sepsis and MOF but appears to be favorable with respect to outcome of sepsis and MOF following multiple trauma. Further research should focus on the pathomechanisms and the possible arising therapeutic options.

Outcome of subtrochanteric femur resection in patients with spinal cord injuries.

OBJECTIVE: To analyse the clinical outcome of subtrochanteric femur resection in patients with infected hip joints caused by pressure ulcers (PUs) in patients following spinal cord injury (SCI). METHOD: A retrospective cohort study, carried out between January 2004 and December 2015. Only patients receiving a subtrochanteric femur resection were included. SCI patients were treated for a hip joint infection caused by a PU. Primary outcome measures were to work out the revision rates and the rate of heterotopic ossification occurrence. RESULTS: At the time of admission, 37 out of the 56 participating patients (66.1%) showed a category IV PU with the ischium being most commonly affected (n=25, 44.6%). The subtrochanteric femur resection was combined either with a direct wound closure (n=29; 51.8%) or a myocutaneous flap (n=27; 48.2%). The mean number of surgeries was 2.6 (1-4; SD=1.6) and 21 patients were successfully treated by a single surgery. Of the patients, 28 had wound healing disorders (50%) and required a revision surgery, and 24 (42.9%) developed a postoperative heterotopic ossification. CONCLUSION: Hip joint infection caused by PUs can be treated with subtrochanteric femur resection. However, the number of postoperative complications is still high

First-in-Man Intrathecal Application of Neurite Growth-Promoting Anti-Nogo-A Antibodies in Acute Spinal Cord Injury.

BACKGROUND: Neutralization of central nervous system neurite growth inhibitory factors, for example, Nogo-A, is a promising approach to improving recovery following spinal cord injury (SCI). In animal SCI models, intrathecal delivery of anti-Nogo-A antibodies promoted regenerative neurite growth and functional recovery. OBJECTIVE: This first-in-man study assessed the feasibility, safety, tolerability, pharmacokinetics, and preliminary efficacy of the human anti-Nogo-A antibody ATI355 following intrathecal administration in patients with acute, complete traumatic paraplegia and tetraplegia. METHODS: Patients (N = 52) started treatment 4 to 60 days postinjury. Four consecutive dose-escalation cohorts received 5 to 30 mg/2.5 mL/day continuous intrathecal ATI355 infusion over 24 hours to 28 days. Following pharmacokinetic evaluation, 2 further cohorts received a bolus regimen (6 intrathecal injections of 22.5 and 45 mg/3 mL, respectively, over 4 weeks). RESULTS: ATI355 was well tolerated up to 1-year follow-up. All patients experienced ≥1 adverse events (AEs). The 581 reported AEs were mostly mild and to be expected following acute SCI. Fifteen patients reported 16 serious AEs, none related to ATI355; one bacterial meningitis case was considered related to intrathecal administration. ATI355 serum levels showed dose-dependency, and intersubject cerebrospinal fluid levels were highly variable after infusion and bolus injection. In 1 paraplegic patient, motor scores improved by 8 points. In tetraplegic patients, mean total motor scores increased, with 3/19 gaining >10 points, and 1/19 27 points at Week 48. Conversion from complete to incomplete SCI occurred in 7/19 patients with tetraplegia. CONCLUSIONS: ATI335 was well tolerated in humans; efficacy trials using intrathecal antibody administration may be considered in acute SCI.

Clinical Prediction Rule for Heterotopic Ossification of the Hip in Patients with Spinal Cord Injury.

STUDY DESIGN: A case-control study; clinical prediction rule. OBJECTIVE: The aim of this study was to construct and internally validate a clinical prediction rule to identify patients at high risk of developing heterotopic ossification (HO) after spinal cord injury (SCI). SUMMARY OF BACKGROUND DATA: HO after SCI can lead to loss of joint mobility, loss of function, peripheral nerve entrapment, and pressure sores. HO is usually diagnosed on the basis of clinical symptoms, as no laboratory tests are yet available to identify patients with early HO formation. Risk factors include a complete SCI; patient age; spasticity; urinary tract infection (UTI); pneumonia; pelvic trauma; cervical or thoracic injury; and pressure sores. METHODS: We analyzed a total of 558 patients with SCI, of whom 221 developed HO of the hip. A parametric survival model was fitted to estimate the probability of developing HO of the hip within 3 months of a SCI. Hazard ratios (HRs) calculation, internal validation, calibration, and model reduction were performed over 200 bootstrapped resamples. A risk score for clinical used was developed. RESULTS: Risk factors contributing to the risk score were completeness of the injury, age, sex, UTI, spasticity, and pneumonia. The model demonstrated good discrimination (AUC = 0.72). According to the risk score quintiles, the risk of developing HO after SCI was 1.0 for persons with a score of 0 to 17 and increased 2.47-fold for persons with a score of 1 to 21, 4.75-fold for persons with a score of 22 to 27, 6.95-fold for persons with a score of 28 to 31, and 9.23-fold for persons with a score of 32-35. CONCLUSION: The risk score demonstrated good discrimination in predicting the occurrence of HO within 3 months of a SCI. Further development and validation of the model in other populations is warranted. LEVEL OF EVIDENCE: 3.

Hybrid Assistive Limb Exoskeleton HAL in the Rehabilitation of Chronic Spinal Cord Injury: Proof of Concept; the Results in 21 Patients.

INTRODUCTION: The use of mobile exoskeletons is becoming more and more common in the field of spinal cord injury (SCI) rehabilitation. The hybrid assistive limb (HAL) exoskeleton provides a tailored support depending on the patient's voluntary drive. MATERIALS AND METHODS: After a pilot study in 2014 that included 8 patients with chronic SCI, this study of 21 patients with chronic SCI serves as a proof of concept. It was conducted to provide further evidence regarding the efficacy of exoskeletal-based rehabilitation. Functional assessment included walking speed, distance, and time on a treadmill, with additional analysis of functional mobility using the following tests: 10-meter walk test (10MWT), timed up and go (TUG) test, 6-minute walk test (6MWT), and the walking index for SCI II (WISCI-II) score. RESULTS: After a training period of 90 days, all 21 patients significantly improved their functional and ambulatory mobility without the exoskeleton. Patients were assessed by the 6MWT, the TUG test, and the 10MWT, which also indicated an increase in the WISCI-II score along with significant improvements in HAL-associated walking speed, distance, and time. CONCLUSION: Although, exoskeletons are not yet an established treatment in the rehabilitation of spinal cord injuries, the devices will play a more important role in the future. The HAL exoskeleton training enables effective, body weight-supported treadmill training and is capable of improving ambulatory mobility. Future controlled studies are required to enable a comparison of the new advances in the field of SCI rehabilitation with traditional over-ground training.

Functional Outcome of Neurologic-Controlled HAL-Exoskeletal Neurorehabilitation in Chronic Spinal Cord Injury: A Pilot With One Year Treatment and Variable Treatment Frequency.

STUDY DESIGN: Longitudinal prospective study. OBJECTIVES: Whether 1-year HAL-BWSTT of chronic spinal cord injured patients can improve independent ambulated mobility further as a function of training frequency, after an initial 3-month training period. METHODS: Eight patients with chronic SCI were enrolled. They initially received full standard physical therapy and neurorehabilitation in the acute/subacute posttrauma phase. During this trial, all patients first underwent a daily (5 per week) HAL-BWSTT for 12 weeks. Subsequently, these patients performed a 40-week HAL-BWSTT with a training session frequency of either 1 or 3 to 5 sessions per week. The patients' functional status including HAL-associated treadmill-walking time, -distance, and -speed with additional analysis of gait pattern, and their independent (without wearing the robot suit) functional mobility improvements, were assessed using the 10-Meter-Walk Test (10MWT), Timed-Up-and-Go Test (TUG) and 6-Minute-Walk Test (6MinWT) on admission, at 6 weeks, 12 weeks, and 1 year after enrollment. The data were analyzed separately for the 2 training frequency subgroups after the initial 12-week training period, which was identical in both groups. RESULTS: During the 1-year follow-up, HAL-associated walking parameters and independent functional improvements were maintained in all the patients. This result held irrespective of the training frequency. CONCLUSIONS: Long-term 1-year maintenance of HAL-associated treadmill walking parameters and of improved independent walking abilities after initial 12 weeks of daily HAL-BWSTT is possible and depends mainly on the patients' ambulatory status accomplished after initial training period. Subsequent regular weekly training, but not higher frequency training, seems to be sufficient to preserve the improvements accomplished.

Against the odds: what to expect in rehabilitation of chronic spinal cord injury with a neurologically controlled Hybrid Assistive Limb exoskeleton. A subgroup analysis of 55 patients according to age and lesion level.

Objective Age and lesion level are believed to represent outcome predictors in rehabilitation of patients with chronic spinal cord injury (SCI). The Hybrid Assistive Limb (HAL) exoskeleton enables patients to perform a voluntary controlled gait pattern via an electromyography-triggered neuromuscular feedback system, and has been introduced as a temporary gait training tool in patients with SCI. The aim of this prospective pre- and postintervention study was to examine functional outcomes as a function of age and lesion level in patients with chronic incomplete SCI (iSCI) or chronic complete SCI (cSCI) with zones of partial preservation (ZPP) by using the HAL as a temporary training tool. Methods Fifty-five participants with chronic iSCI or cSCI (mean time since injury 6.85 ± 5.12 years) were classified according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and divided by age (< 50 or ≥ 50 years), independent of lesion level, and also into 4 homogeneous groups according to lesion level. The subgroups were as follows: Subgroup 1, tetraplegic iSCI (n = 13) (C2-8, AIS C [n = 8] and AIS D [n = 5]); Subgroup 2, paraplegic iSCI with spastic motor behavior (n = 15) (T2-12, AIS C [n = 8] and AIS D [n = 7]); Subgroup 3, paraplegic cSCI with complete motor paraplegia and absence of spastic motor behavior (n = 18) (T11-L4 [AIS A], and ZPP from L-3 to S-1); and Subgroup 4, paraplegic iSCI with absence of spastic motor behavior (n = 9) (T12-L3, AIS C [n = 8] and AIS D [n = 1]). The training paradigm consisted of 12 weeks of HAL-assisted treadmill training (5 times/week). Baseline status was documented prior to intervention by using the AIS grade, Walking Index for SCI II (WISCI II) score, the 10-meter walk test (10MWT), and the 6-minute walk test (6MinWT). Training effects were assessed after 6 and 12 weeks of therapy, without HAL assistance. Results Overall, a time reduction of 47% in the 10MWT, self-selected speed (10MWTsss) (< 50 years = 56% vs ≥ 50 years = 37%) and an increase of 50% in the 6MinWT were documented. The WISCI II scores showed a mean gain of 1.69 levels. At the end of the study, 24 of 55 patients (43.6%) were less dependent on walking aids. Age had a nonsignificant negative influence on the 10MWTsss. Despite a few nonsignificant subgroup differences, participants improved across all tests. Namely, patients with iSCI who had spastic motor behavior improved to a nonsignificant, lesser extent in the 6MinWT. Conclusions The HAL-assisted treadmill training leads to functional improvements in chronic iSCI or cSCI, both in and out of the exoskeleton. An improvement of approximately 50% in the 10MWTsss and in gait endurance (6MinWT) can be expected from such training. The influences of SCI lesion level and age on functional outcome were nonsignificant in the present study. Older age (≥ 50 years) may be associated with smaller improvements in the 10MWTsss. An iSCI in paraplegic patients with spastic motor behavior may be a nonsignificant negative predictor in gait endurance improvements. Clinical trial registration no.: DRKS00010250 ( https://drks-neu.uniklinik-freiburg.de/drks_web/setLocale_DE.do ).

Muscle localization of heterotopic ossification following spinal cord injury.

BACKGROUND CONTEXT: Heterotopic ossification (HO) is a known complication especially in people with traumatic spinal cord injury (SCI). Although some risk factors have already been described, the pathophysiology of HO is still unknown. The pelvis is the most common region for HO occurrence. However, the prevalence of HO by muscle groups about the hip is not well described. PURPOSE: To analyze the prevalence of early HO in muscle groups about the hip in 267 patients with SCI. PATIENT SAMPLE: 267 patients with traumatic SCI and pelvic HO. METHODS: Between January 2001 and December 2014, 267 patients with SCI were treated in our university hospital and were included in the study. Patients were routinely screened for HO using ultrasound. The diagnosis of HO was validated using magnetic resonance imaging (MRI) or computed tomography (CT). The primary outcome measure was the prevalence of HO by muscle groups around the hip. The following muscle groups around the hip were defined: (1) gluteal group, (2) adductor group, (3) iliopsoas group, and (4) deep muscle group. Additionally, the prevalence of concomitant trochanteric bursitis was recorded in all cases. RESULTS: The gluteal group showed the highest HO prevalence with 55.8%, followed by the deep muscle group with 31.1%. Concomitant trochanteric bursitis was found in 62 patients (23.2%). No association between pelvic trauma and HO development was observed (n=16, 11%). CONCLUSIONS: The most common muscular location for the occurrence of HO about the hip was the gluteal muscle group. Considering that no laboratory parameters are currently available for screening for HO, highly sensitive ultrasound screening examinations should be routinely performed, with particular attention paid to the gluteal muscles. Additionally, routine range of motion examination for extension and external rotation of the hip joint is warranted.

Heterotopic ossification mimicking infection in patients with traumatic spinal cord injury.

BACKGROUND: Heterotopic ossification (HO) is a common concominant condition in patients with traumatic spinal cord injury (SCI). In this context, we report on patients with heterotopic ossification causing infection like symptoms as a first manifestation of HO subsequent to traumatic SCI. OBJECTIVE: The objective of the study was to analyse possible ``early-indicator symptoms'' in patients suffering from heterotopic ossification following SCI with special focus on elevated serum CRP, serum CK and body temperature. METHODS: All eligible patients treated between January 2004 and December 2013 because of a SCI and heterotopic ossification have been enrolled in this retrospective study. An age below 18 years and the absence of the combination of elevated serum CRP, CK and elevated body temperature (> 38.5 °C) were defined as exclusion criteria. The presence of another infection, led to exclusion. Fifteen out of 235 patients (6.4%) met the inclusion criteria and were included in the final data analysis. RESULTS: The patient cohort consists of 13 male and two female patients with a mean age of 30.6 years (range from 18 to 56 years; SD = 13.5). The mean time interval between HO development and the injury was 49.4 days (range from 16 to 131 days; SD = 34.3). Focussing on laboratory parameters, mean serum CRP level was 10.2 mg/dl (range from 1.3 to 24.4 mg/dl; SD = 9.6). Mean serum CK was 1365 U/l (range from 255 to 4729 U/l; SD = 1491). Worth mentioning, in 9 cases (60%) serum CK was higher than 500 U/l. Mean body temperature was 38.7 °C (range from 38.0 to 39.4; SD = 0.4). CT scans of the thorax, abdomen and pelvis revealed no further pathologies besides the heterotopic ossification. Urinary tract infections were ruled out, using urine tests as a standard procedure in all cases. CONCLUSIONS: Elevated levels of serum CRP, serum CK and high body temperature in acute SCI may be considered as indicators for a concominant HO diagnosis.

Impact of locomotion training with a neurologic controlled hybrid assistive limb (HAL) exoskeleton on neuropathic pain and health related quality of life (HRQoL) in chronic SCI: a case study (.).

Chronic neuropathic pain (CNP) is a common condition associated with spinal cord injury (SCI) and has been reported to be severe, disabling and often treatment-resistant and therefore remains a clinical challenge for the attending physicians. The treatment usually includes pharmacological and/or nonpharmacological approaches. Body weight supported treadmill training (BWSTT) and locomotion training with driven gait orthosis (DGO) have evolved over the last decades and are now considered to be an established part in the rehabilitation of SCI patients. Conventional locomotion training goes along with improvements of the patients' walking abilities in particular speed and gait pattern. The neurologic controlled hybrid assistive limb (HAL®, Cyberdyne Inc., Ibraki, Japan) exoskeleton, however, is a new tailored approach to support motor functions synchronously to the patient's voluntary drive. This report presents two cases of severe chronic and therapy resistant neuropathic pain due to chronic SCI and demonstrates the beneficial effects of neurologic controlled exoskeletal intervention on pain severity and health-related quality of life (HRQoL). Both of these patients were engaged in a 12 weeks period of daily HAL®-supported locomotion training. In addition to improvements in motor functions and walking abilities, both show significant reduction in pain severity and improvements in all HRQoL domains. Although various causal factors likely contribute to abatement of CNP, the reported results occurred due to a new approach in the rehabilitation of chronic spinal cord injury patients. These findings suggest not only the feasibility of this new approach but in conclusion, demonstrate the effectiveness of neurologic controlled locomotion training in the long-term management of refractory neuropathic pain. Implications for Rehabilitation CNP remains a challenge in the rehabilitation of chronic SCI patients. Locomotion training with the HAL exoskeleton seems to improve CNP in chronic SCI. HAL locomotion training is feasible and safe in the rehabilitation of chronic SCI patients.

Patients with thoracic trauma and concomitant spinal cord injury have a markedly decreased mortality rate compared to patients without spinal cord injury.

INTRODUCTION: The present study was performed to compare the clinical outcome, with special focus on the mortality rate of thoracic injuries, in patients with and without spinal cord injury. MATERIALS AND METHODS: Patients who were treated for thoracic trauma at our institution between January 1998 and December 2007 were included in this retrospective cohort study. Patients were divided into two groups according to whether they had suffered a concomitant spinal cord injury (SCI) (N = 54) or not (N = 61). Survival analysis was performed using the Kaplan-Meier function and the Cox proportional hazards model. Age, sex, injury severity score (ISS), Charlson comorbidity index (CCI), and infection with pneumonia were included as covariates in the final model. RESULTS: Patients with SCI have a 65 % reduction in the chance of dying compared to patients without SCI following thoracic trauma (HR = 0.35; 95%CI = 0.13-0.96; p = 0.041). Sex (HR = 0.67; 95 % CI: 0.26-1.71, P = 0.141), ISS > =25 (HR = 2.08 95 % CI: 0.58-7.49, P = 2.63) and a Charlson Comorbidity Index of 2 (HR = 1.82; 95 % CI: 0.58-7.22, P = 0.393) had no effect in the risk of dying. However, patients older than 60 years had four times the chance of dying than patients younger than 30 years (HR = 4.39; 95 % CI: 1.02-19, P = 0.048). Patients with pneumonia had a nonsignificant twofold increase in the risk of dying (HR = 2.28; 95 % CI: 0.97-5.34, P = 0.059). CONCLUSIONS: Our results demonstrate that patients with thoracic trauma and concomitant SCI had markedly decreased mortality compared to patients without SCI, even after adjusting for age, sex, injury severity, comorbidities and pneumonia infection.

HAL® exoskeleton training improves walking parameters and normalizes cortical excitability in primary somatosensory cortex in spinal cord injury patients.

BACKGROUND: Reorganization in the sensorimotor cortex accompanied by increased excitability and enlarged body representations is a consequence of spinal cord injury (SCI). Robotic-assisted bodyweight supported treadmill training (BWSTT) was hypothesized to induce reorganization and improve walking function. OBJECTIVE: To assess whether BWSTT with hybrid assistive limb® (HAL®) exoskeleton affects cortical excitability in the primary somatosensory cortex (S1) in SCI patients, as measured by paired-pulse somatosensory evoked potentials (ppSEP) stimulated above the level of injury. METHODS: Eleven SCI patients took part in HAL® assisted BWSTT for 3 months. PpSEP were conducted before and after this training period, where the amplitude ratios (SEP amplitude following double pulses - SEP amplitude following single pulses) were assessed and compared to eleven healthy control subjects. To assess improvement in walking function, we used the 10-m walk test, timed-up-and-go test, the 6-min walk test, and the lower extremity motor score. RESULTS: PpSEPs were significantly increased in SCI patients as compared to controls at baseline. Following training, ppSEPs were increased from baseline and no longer significantly differed from controls. Walking parameters also showed significant improvements, yet there was no significant correlation between ppSEP measures and walking parameters. CONCLUSIONS: The findings suggest that robotic-assisted BWSTT with HAL® in SCI patients is capable of inducing cortical plasticity following highly repetitive, active locomotive use of paretic legs. While there was no significant correlation of excitability with walking parameters, brain areas other than S1 might reflect improvement of walking functions. EEG and neuroimaging studies may provide further information about supraspinal plastic processes and foci in SCI rehabilitation.

Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study.

BACKGROUND CONTEXT: Treadmill training after traumatic spinal cord injury (SCI) has become an established therapy to improve walking capabilities. The hybrid assistive limb (HAL) exoskeleton has been developed to support motor function and is tailored to the patients' voluntary drive. PURPOSE: To determine whether locomotor training with the exoskeleton HAL is safe and can increase functional mobility in chronic paraplegic patients after SCI. DESIGN: A single case experimental A-B (pre-post) design study by repeated assessments of the same patients. The subjects performed 90 days (five times per week) of HAL exoskeleton body weight supported treadmill training with variable gait speed and body weight support. PATIENT SAMPLE: Eight patients with chronic SCI classified by the American Spinal Injury Association (ASIA) Impairment Scale (AIS) consisting of ASIA A (zones of partial preservation [ZPP] L3-S1), n=4; ASIA B (with motor ZPP L3-S1), n=1; and ASIA C/D, n=3, who received full rehabilitation in the acute and subacute phases of SCI. OUTCOME MEASURES: Functional measures included treadmill-associated walking distance, speed, and time, with additional analysis of functional improvements using the 10-m walk test (10MWT), timed-up and go test (TUG test), 6-minute walk test (6MWT), and the walking index for SCI II (WISCI II) score. Secondary physiologic measures including the AIS with the lower extremity motor score (LEMS), the spinal spasticity (Ashworth scale), and the lower extremity circumferences. METHODS: Subjects performed standardized functional testing before and after the 90 days of intervention. RESULTS: Highly significant improvements of HAL-associated walking time, distance, and speed were noticed. Furthermore, significant improvements have been especially shown in the functional abilities without the exoskeleton for over-ground walking obtained in the 6MWT, TUG test, and the 10MWT, including an increase in the WISCI II score of three patients. Muscle strength (LEMS) increased in all patients accompanied by a gain of the lower limb circumferences. A conversion in the AIS was ascertained in one patient (ASIA B to ASIA C). One patient reported a decrease of spinal spasticity. CONCLUSIONS: Hybrid assistive limb exoskeleton training results in improved over-ground walking and leads to the assumption of a beneficial effect on ambulatory mobility. However, evaluation in larger clinical trials is required.

Risk factors for heterotopic ossification in patients with spinal cord injury: a case-control study of 264 patients.

STUDY DESIGN: Case-control study. OBJECTIVE: We designed a case-control study to analyze the risk factors associated with the development of heterotopic ossification (HO) in patients with traumatic spinal cord injury. SUMMARY OF BACKGROUND DATA: Patients with spinal cord injury have a high risk of developing HO, although the exact etiopathogenesis is still unknown. Several factors are known to be potential risk factors. However, we are not aware of any large clinical studies evaluating the risk factors for HO. METHODS: Patients who were treated for a traumatic spinal cord injury in our hospital, and who subsequently developed HO, were identified by querying the electronic database at our hospital from 2002 to 2010. One hundred thirty-two patients and 132 controls were included. Our primary outcome measures were the risk of developing HO according to whether the patient had experienced a complete spinal cord lesion according to American Spinal Injury Association Impairment Scale; tetraplegia or paraplegia; cervical, thoracic, or lumbar injury; severe chest trauma; and the time interval between injury and surgery. Secondary risk factors explored were patient age; sex; presence and number of comorbidities; length of hospital and intensive care unit stay; associated traumatic injuries; presence of spasticity, pressure ulcers, deep venous thrombosis, and urinary tract infection; and pulmonary complications, such as pneumonia and necessity of tracheostomy. RESULTS: Patients with associated spasticity and thoracic trauma, complete lesion, pneumonia, presence of tracheostomy, and urinary tract infection had a higher risk of developing HO. CONCLUSION: Adequate management of potential risk factors could help reduce the overall incidence of HO and outcome in patients with traumatic spinal cord injury.

Rhabdomyolysis after heterotopic ossification: an unusual complication in a spinal cord injured patient.

PURPOSE: Loss of joint mobility, resulting loss of function peripheral nerve entrapment and pressure sores are the known complications of heterotopic ossification. METHODS: We reported about a 32-year-old male patient, referred to our clinic presenting with incomplete tetraplegia after a motorcycle accident. The patient developed a HO in both hips 19 days after injury. Single-dose radiation therapy with 7 Gy with an electrode voltage of 15 MeV was performed. RESULTS: One month after radiation therapy, the patient developed a fever of 104ºF and blood tests showed increased C-reactive protein (CRP), creatinine kinase (CK), serum myoglobin and dark-colored urine due to myoglobinuria. Further diagnostic measures showed only massive recurrent HO. With the suspicion of a possible case of rhabdomyolysis due to the severe muscular distension caused by the recurrent HO, the patient was transferred to our intermediate care unit for further treatment. Forced diureses were applied to reduce the high levels of CK in blood. However, laboratory monitoring showed a further increase in CRP, CK (15,000 U/l) and myoglobin. A repeated radiation therapy was undertaken in a time interval of 14 days. After radiation therapy, a control MRI was performed and no signs of florid HO were visualized, CRP, CK, myoglobin, as well as body temperature and urine colour, had returned to normal and the patient was feeling well. CONCLUSIONS: We report the case of our patient to increase awareness among physicians and training staff working with patients with a spinal cord injury to expedite the diagnosis of rhabdomyolysis in the setting of HO and SCI.

Necrotizing fasciitis in patients with spinal cord injury: an analysis of 25 patients.

STUDY DESIGN: Retrospective chart review. OBJECTIVE: The aim of this study was to analyze the correlation between necrotizing fasciitis (NF) and pressure ulcers, as well as the mortality, and complication rate, in patients with spinal cord injury (SCI). SUMMARY OF BACKGROUND DATA: Pressure ulcers represent a challenging problem, especially in immobilized patients. Necrotizing soft tissue infections arising from decubitus ulcers in patients with SCIs have been reported. METHODS: Twenty-five SCI patients with NF treated between April 2000 and December 2009 were included in the study. All patients were analyzed in regard to the number of surgical debridements, length of hospital stay, and laboratory, microbiological, and histological assessments. Information about age, sex, preexisting conditions, anatomical localization, and etiology of the NF were acquired from the patients' medical records. RESULTS: There were 19 paraplegic and 6 tetraplegic patients with a median age of 47 years. In 18 cases, NF developed in the setting of pressure sores. Grade 4 pressure sores were identified in 15 cases and grade 3 pressure sores in 3 cases. The incidence of developing NF is significantly higher in patients with fourth-grade pressure sores than in those with a lower-grade lesion (odds ratio = 2.91; 95% confidence interval, 1.29-6.56). The mean laboratory risk indicator for NF score was 6.6 upon admission. The most common bacteria were streptococci. During the hospital stay, six patients developed sepsis and two died because of septic multiorgan failure. CONCLUSION: Patients with grade 3 and 4 pressure sores had a significantly increased risk of developing NF. The current investigators recommend that close clinical and laboratory monitoring of all patients with grade 3 or 4 pressure sores is appropriate so that any early clinical signs of NF can be recognized and evaluated for early and aggressive treatment.

Rare complication after VAC-therapy in the treatment of deep sore ulcers in a paraplegic patient.

The VAC-therapy is a safe, easy, and effective therapy for the management of chronic wounds. Known advantages of the VAC technique are the quicker wound healing by stimulating the blood flow, the formation of granulation tissue, angiogenesis, and cell proliferation. The use of negative pressure treatment can decrease the number of dressing changes and length of hospital stay. However, some related complications after and during VAC therapy have been described. We here describe a rare complication during the treatment of severe os ischium sore with VAC therapy, which has not been reported in the literature yet. We report about a 43-year-old paraplegic patient, referred to our clinic from a regional hospital where he had been admitted 2 months earlier, presenting with a necrotizing fasciitis after VAC therapy during the treatment of fourth grade os ischium sore. After operative debridement and long-term antibiotics with Ciprofloxacin soft tissue closure was performed using a myocutaneous tensor fascia lata flap. Temporary stabilization was achieved by a triangle external fixateur attached to the right femur and the pelvis. After 1 week the tapping point of the muscle flap could be covered with local skin mesh-graft from the right calf as a donor site. The patient was mobilized in a wheelchair and was discharged home 3 months after admission. The VAC technique is a safe, easy, and effective means in chronic wound care management. However, the described rare complication should be kept in mind. The clinical management of VAC therapy requires a distinct indication and close clinical monitoring by experienced medical professionals. The use of VAC therapy in fourth grade sores may have deleterious consequences for the patient.