Neurological recovery after early versus delayed surgical decompression for acute traumatic spinal cord injury.

The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI). Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research.

Design recommendations for exoskeletons: Perspectives of individuals with spinal cord injury.

OBJECTIVE: This study investigated the expectations of individuals with spinal cord injury (SCI) regarding exoskeletons. DESIGN: The survey consisted out of questions regarding multiple aspects of exoskeleton technology. SETTING: An online survey was distributed via the monthly newsletter of the Dutch Patient Association for Spinal Cord Injury (SCI). PARTICIPANTS: Individuals with SCI who are members of the Dutch Patient Association for SCI. OUTCOME MEASURES: General impression of exoskeleton technology, expectations regarding capabilities and user-friendliness, training expectations and experiences, future perspectives and points of improvement. RESULTS: The survey was filled out by 95 individuals with SCI, exoskeletons were considered positive and desirable by 74.7%. About 11 percent (10.5%) thought one could ambulate faster, or just as fast, while wearing an exoskeleton as able-bodied people. Furthermore, 18.9% expected not to use a wheelchair or walking aids while ambulating with the exoskeleton. Twenty-five percent believed that exoskeletons could replace wheelchairs. Some main points of improvement included being able to wear the exoskeleton in a wheelchair and while driving a car, not needing crutches while ambulating, and being able to put the exoskeleton on by oneself. CONCLUSION: Individuals with SCI considered exoskeletons as a positive and desirable innovation. But based on the findings from the surveys, major points of improvement are necessary for exoskeletons to replace wheelchairs in the future. For future exoskeleton development, we recommend involvement of individuals with SCI to meet user expectations and improve in functionality, usability and quality of exoskeletons.

What Are the Risk Factors for Mechanical Failure and Loosening of a Transfemoral Osseointegrated Implant System in Patients with a Lower-limb Amputation?

BACKGROUND: Septic loosening and stem breakage due to metal fatigue is a rare but well-known cause of orthopaedic implant failure. This may also affect the components of the osseointegrated implant system for individuals with transfemoral amputation who subsequently undergo revision. Identifying risk factors is important to minimize the frequency of revision surgery after implant breakage. QUESTIONS/PURPOSES: (1) What proportion of patients who received an osseointegrated implant after transfemoral amputation underwent revision surgery, and what were the causes of those revisions? (2) What factors were associated with revision surgery when stratified by the location of the mechanical failure and (septic) loosening (intramedullary stem versus dual cone adapter)? METHODS: Between May 2009 and July 2015, we treated 72 patients with an osseointegrated implant. Inclusion criteria were a minimum follow-up of 5-years and a standard press-fit cobalt-chromium-molybdenum (CoCrMb) transfemoral osseointegrated implant. Based on that, 83% (60 of 72) of patients were eligible; a further 3% (2 of 60) were excluded because of no received informed consent (n = 1) and loss to follow-up (n = 1). Eventually, we included 81% (58 of 72) of patients for analysis in this retrospective, comparative study. We compared patient characteristics (gender, age, and BMI), implant details (diameter of the intramedullary stem, length of the dual cone, and implant survival time), and event characteristics (infectious complications and distal bone resorption). The data were retrieved from our electronic patient file and from our cloud-based database and analyzed by individuals not involved in patient care. Failures were categorized as: (1) mechanical failures, defined as breakage of the intramedullary stem or dual-cone adapter, or (2) (septic) loosening of the osseointegrated implant. RESULTS: Thirty-four percent (20 of 58) of patients had revision surgery. In 12% (7 of 58) of patients, the reason for revision was due to intramedullary stem failures (six breakages, one septic loosening), and in 22% (13 of 58) of patients it was due to dual-cone adaptor failure (10 weak-point breakages and four distal taper breakages; one patient broke both the weak-point and the dual-cone adapter). Smaller median stem diameter (failure: 15 mm [interquartile range 1.3], nonfailure: 17 mm [IQR 2.0], difference of medians 2 mm; p < 0.01) and higher median number of infectious events (failure: 6 [IQR 11], nonfailure: 1 [IQR 3.0], difference of medians -5; p < 0.01) were associated with revision intramedullary stem surgery. No risk factors could be identified for broken dual-cone adapters. CONCLUSION: Possible risk factors for system failure of this osteointegration implant include small stem diameter and high number of infectious events. We did not find factors associated with dual-cone adapter weak-point failure and distal taper failure, most likely because of the small sample size. When treating a person with a lower-limb amputation with a CoCrMb osseointegrated implant, we recommend avoiding a small stem diameter. Further research with longer follow-up is needed to study the success of revised patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

Predictors of exoskeleton motor learning in spinal cord injured patients.

PURPOSE OF THE ARTICLE: Learning to use an exoskeleton is time consuming and diverse between users. Knowledge about trainability of exoskeleton skills is relevant for planning and expectation management. The objective was to assess predictors of exoskeleton skill performance during and after exoskeleton training. MATERIALS AND METHODS: Twenty-four participants with a motor complete spinal cord injury were given 24 training sessions in 8 weeks. Nine potential predictors were identified: lesion level, age, gender, age at injury, time since injury, BMI, sport, active lifestyle, and anxiety. Univariate and multivariate linear regression analyses were performed to examine predictors of skill performance after 2, 4, 6, and 8 weeks. RESULTS AND CONCLUSIONS: Twenty participants completed the training. Univariate analysis revealed that positive predictors were: low lesion level and more active lifestyle after 2 weeks, whereas low age at injury, low BMI, and more active lifestyle were positive predictors after 6 weeks. Multivariate regression model explained 65% of the performance after 2 weeks (predictors: lesion level, anxiety, active lifestyle) and 66% after 6 weeks (predictors: BMI, active lifestyle, age). Lesion level was a predictor during the first 4 weeks, but did not influence participants' final skill level. BMI, age, and active lifestyle were predictors toward the end of the training period.Implications for rehabilitationWith the help of wearable exoskeletons people with a complete spinal cord injury can regain their standing and walking mobility.Learning to use an exoskeleton is time consuming and the number of training sessions required to walk independently differs greatly between users.This study shows that lesion level was an important predictor of exoskeleton motor learning in the first 4 weeks of training.BMI, age, and active lifestyle were predictors of exoskeleton skill performance toward the end of the 8 week training period.

Management of the sciatic nerve during transfemoral amputation: a survey of Dutch surgeons.

BACKGROUND: Neuropathic pain often occurs after leg amputation. It is unclear why some patients suffer from pain and others do not. Intraoperative nerve handling might correlate with these pain syndromes. It is unknown which nerve handling techniques are currently used among surgeons and whether a specific technique is related to eliciting these pain syndromes. The aim of this study was to investigate the current surgical sciatic nerve management used among surgeons in the Netherlands. METHODS: A survey was carried out among Dutch surgeons. Additionally, surgical sciatic nerve management data were obtained from the surgical reports of transfemoral amputations that were performed in our hospital. RESULTS: Seventy-eight of the 102 online surveys were returned. Sharp transection without ligation was used most often (41.0%), followed by sharp transection after ligation (30.8%). There were 38 transfemoral amputations performed in our hospital. Sharp transection after ligation was most often used (55.3%), followed by transection with electrocautery (13.2%). CONCLUSIONS: All techniques of transecting the sciatic nerve are currently performed by Dutch surgeons. These results provide a solid basis to perform future studies to investigate whether a specific surgical technique is related to postamputation pain syndromes.

Highest ambulatory speed using Lokomat gait training for individuals with a motor-complete spinal cord injury: a clinical pilot study.

BACKGROUND: Motor impairment and loss of ambulatory function are major consequences of a spinal cord injury (SCI). Exoskeletons are robotic devices that allow SCI patients with limited ambulatory function to walk. The mean walking speed of SCI patients using an exoskeleton is low: 0.26 m/s. Moreover, literature shows that a minimum speed of 0.59 m/s is required to replace wheelchairs in the community. OBJECTIVE: To investigate the highest ambulatory speed for SCI patients in a Lokomat. METHODS: This clinical pilot study took place in the Rehabilitation Center Kladruby, in Kladruby (Czech Republic). Six persons with motor-complete sub-acute SCI were recruited. Measurements were taken at baseline and directly after a 30 min Lokomat training. The highest achieved walking speed, vital parameters (respiratory frequency, heart rate, and blood pressure), visual analog scale for pain, and modified Ashworth scale for spasticity were recorded for each person. RESULTS: The highest reached walking speed in the Lokomat was on average 0.63 m/s (SD 0.03 m/s). No negative effects on the vital parameters, pain, or spasticity were observed. A significant decrease in pain after the Lokomat training was observed: 95% CI [0.336, 1.664] (p = 0.012). CONCLUSION: This study shows that it is possible for motor-complete SCI individuals to ambulate faster on a Lokomat (on average 0.63 m/s) than what is currently possible with over-ground exoskeletons. No negative effects were observed while ambulating on a Lokomat. Further research investigating walking speed in exoskeletons after SCI is recommended.

Cost-effectiveness of an integrated 'fast track' rehabilitation service for multi-trauma patients: A non-randomized clinical trial in the Netherlands.

BACKGROUND: Multidisciplinary rehabilitation has been recommended for multi-trauma patients, but there is only low-quality evidence to support its use with these patients. This study examined whether a Supported Fast track multi-Trauma Rehabilitation Service (Fast Track) was cost-effective compared to conventional trauma rehabilitation service (Care As Usual) in patients with multi-trauma from a societal perspective with a one-year follow-up. METHODS: An economic evaluation alongside a prospective, multi-center, non-randomized, controlled clinical study, was conducted in the Netherlands. The primary outcome measure was the Functional Independence Measure (FIM). Generic Quality of Life and Quality Adjusted Life Years (QALYs) of the patients were derived using the Short-form 36 Health Status Questionnaire. Incremental Cost-Effectiveness Ratios (ICERs) were stated in terms of costs per unit of FIM improvement and costs per QALY. To investigate the uncertainty around the ICERs, non-parametric bootstrapping was used. RESULTS: In total, 132 patients participated, 65 Fast Track patients and 67 Care As Usual patients. Mean total costs per person were €18,918 higher in the Fast Track group than in the Care As Usual group. Average incremental effects on the FIM were 3.7 points (in favor of the Fast Track group) and the incremental (extra) bootstrapped costs were €19,033, resulting in an ICER for cost per FIM improvement of €5,177. Care As Usual dominated Fast Track in cost per QALY as it gave both higher QALYs and lower costs. All sensitivity analyses attested to the robustness of our results. CONCLUSIONS: This study demonstrated that a multidisciplinary rehabilitation program for multi-trauma patients according to the supported fast track principle is promising but cost-effectiveness evidence remains inconclusive. In terms of functional outcome, Fast Track was more expensive but yielded also more effects compared to the Care As Usual group. Looking at the costs per QALYs, unfavorable ICERs were found. Given the lack of a willingness-to-pay threshold for functional recovery and the relatively short time horizon, it is not possible to draw firm conclusions about the first. TRIAL REGISTRATION: (Current Controlled Trials register: ISRCTN68246661).

[Osseointegration click-on prosthesis following leg amputation]. / Osseo-integratieklikprothese bij beenamputatie.

Since its introduction in 2009, more than 150 people in the Netherlands have received an osseointegration prosthesis following leg amputation. Serious complications such as septic or aseptic loosening and breakage of the implant are rare. In this article we highlight the results so far, the indications and contra-indications, our first experiences with patients who have undergone amputation due to vascular disease, and the future of osseointegration treatment in the Netherlands.

Pain Exposure Physical Therapy versus conventional treatment in complex regional pain syndrome type 1-a cost-effectiveness analysis alongside a randomized controlled trial.

OBJECTIVE: To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis. DESIGN: Randomized controlled trial with 9 months follow-up. SETTING: Patients were recruited from hospitals and general practitioners in the region around a university hospital. SUBJECTS: A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected. INTERVENTIONS: Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline. MAIN MEASURES: For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score-Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs. RESULTS: No significant effects were found for QALYs (mean difference = -0.02; 95% confidence interval (CI) -0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy. CONCLUSION: This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

Prevention of Complex Regional Pain Syndrome type 1 after conservative reatment of a distal radius fracture with a home exercise program: A proof-of-concept study.

Prevention of CRPS-1, a post-traumatic pain syndrome, after a distal radius fracture is important as this syndrome might lead to chronic pain and serious disabilities. In several studies, it was shown that CRPS-1 can be cured with exercise and graded activities. In a prospective cohort study, a home exercise program with progressive loading exercises was applied immediately after cast removal in patients with a distal radius fracture. After three months, patients were interviewed by telephone using the subjective Budapest diagnostic criteria for CRPS-1. In our study, 56 patients were included and 9 patients (16%) scored positive on the subjective diagnostic criteria. None of the 9 patients was diagnosed with CRPS-1. This study indicates that a home exercise program after conservative treatment of distal radius fracture is a safe and effective option to prevent CRPS-1. A larger study is needed to prove the preventive power of this home exercise program.

Ten Meters Walking Speed in Spinal Cord-Injured Patients: Does Speed Predict Who Walks and Who Rolls?

BACKGROUND: Walking speed is assumed to be a key factor in regaining ambulation after spinal cord injury (SCI). However, from the literature it remains unclear which walking speed usually results in independent community ambulation. OBJECTIVE: The primary aim of this study was to determine at which walking speed SCI patients tend to walk in the community instead of using a wheelchair. The secondary aim was to investigate clinical conditions that favor independent ambulation in the community. METHODS: Data from SCI patients were collected retrospectively from the European Multicenter Study about Spinal Cord Injury database. We determined a cutoff walking speed at which the patients tend to walk in the community by plotting a receiver operating characteristics curve, using the Spinal Cord Independence Measure for outdoor mobility. Univariate analyses investigated which factors influence independent community ambulation. RESULTS: A walking speed of 0.59 m/s is the cutoff between patients who do and do not ambulate independently in the community, with a sensitivity of 91.6% and a specificity of 80.3%. Age, injury severity, and lower limb muscle strength have a significant influence on independent community ambulation. CONCLUSIONS: Patients with an SCI who regain a walking speed of 0.59 m/s tend to achieve a level of walking effectiveness that allows for independent community walking. Although such patients tend to be younger and less severely injured, this walking speed can be a target for locomotor training in rehabilitation and clinical trials that lead to a meaningful outcome level of community walking.

The Magnitude and Time Course of Muscle Cross-section Decrease in Intensive Care Unit Patients.

OBJECTIVE: Bedriddenness and immobilization of patients at an intensive care unit may result in muscle atrophy and devaluation in quality of life. The exact effect of immobilization on intensive care unit patients is not known. The aim of this study was to investigate the magnitude and time course of muscle cross-section decrease in acute critically ill patients admitted to the intensive care unit. DESIGN: An observational pilot study was performed in intensive care unit patients. Data of bilateral ultrasound muscle cross-section measurements of the knee extensors and the elbow flexors were collected. Thirty-four intensive care unit patients were included in this study; data are presented from 14 patients who were measured at least three times. RESULTS: Repeated measures analysis of variance shows a significant decrease in muscle cross-section over time (F1,13 = 80.40, P ≤ 0.001).The decrease in muscle cross-section of the arms was significantly higher (F1,13 = 5.38, P = 0.037) than the decrease of the legs. Four weeks after intensive care unit admission, the muscle cross-section decrease had not reached an asymptote yet. CONCLUSIONS: The muscle cross-section decrease in bedridden intensive care unit patients is significant for a time of 2 to 4 weeks. The decrease in muscle cross-section of the arms is greater than the decrease of the legs.

Effects of an Integrated 'Fast Track' Rehabilitation Service for Multi-Trauma Patients: A Non-Randomized Clinical Trial in the Netherlands.

OBJECTIVES: The effects on health related outcomes of a newly-developed rehabilitation program, called 'supported Fast Track multi-trauma rehabilitation service' (Fast Track), were evaluated in comparison with conventional trauma rehabilitation service (Care as Usual). METHODS: Prospective, multi-center, non-randomized controlled study. Between 2009 and 2012, 132 adult multi-trauma patients were included: 65 Fast Track and 67 Care as Usual patients with an Injury Severity Score ≥16, complex multiple injuries in several extremities or complex pelvic and/or acetabulum fractures. The Fast Track program involved: integrated coordination between trauma surgeon and rehabilitation physician, shorter stay in hospital with faster transfer to a specialized trauma rehabilitation unit, earlier start of multidisciplinary treatment and 'non-weight bearing' mobilization. Primary outcomes were functional status (FIM) and quality of life (SF-36) measured through questionnaires at baseline, 3, 6, 9 and 12 months post-trauma. Outcomes were analyzed using a linear mixed-effects regression model. RESULTS: The FIM scores significantly increased between 0 and 3 months (p<0.001) for both groups showing that they had improved overall, and continued to improve between 3 and 6 months for Fast Track (p = 0.04) and between 3 and 9 months for Care as Usual (p = 0.03). SF-36 scores significantly improved in both groups between 3 and 6 months (Fast Track, p<0.001; Care as Usual, p = 0.01). At 12 months, SF-36 scores were still below (self-reported) baseline measurements of patient health prior to the accident. However, the FIM and SF-36 scores differed little between the groups at any of the measured time points. CONCLUSION: Both Fast Track and Care as Usual rehabilitation programs were effective in that multi-trauma patients improved their functional status and quality of life. A faster (maximum) recovery in functional status was observed for Fast Track at 6 months compared to 9 months for Care as Usual. At twelve months follow-up no differential effects between treatment conditions were found. TRIAL REGISTRATION: ISRCTN68246661.

Periprosthetic cortical bone remodeling in patients with an osseointegrated leg prosthesis.

Qualitative studies have shown that the periprosthetic cortical bone may decrease in the first years after the implantation of an osseointegrated leg prosthesis (OILP) in patients with a transfemoral amputation. The resorption of periprosthetic cortical bone may endanger implant survival because of outbreak fractures and aseptic loosening. A decrease in periprosthetic bone quality may also lead to insufficient bone stock for potential revision surgery. This study quantified the periprosthetic bone changes and skeletal remineralization in 27 patients with an ILP (Integrated Leg Prosthesis)-type transfemoral OILP. Periprosthetic cortical thickness was analyzed from standard anteroposterior (AP) radiographs that were taken immediately postoperatively and at both 12 and 24 months post-implantation. The bone mineral density of the femoral hip neck on both sides was measured pre-operatively with Dual X-ray absorptiometry (DXA) and at 12 and 24 months post-implantation. Compared to that immediately post-operative, the periprosthetic cortical thickness increased significantly by 9.6% (p = 0.020) and 8.9% (p < 0.001) at 12 and 24 months, respectively. The change in bone mineral density of the hip neck on both sides was not significant. In contrast to previous observations, this study reports increased periprosthetic cortical thickness around the OILP implant in the first 2 years after implantation. These data indicate good prospects for implant survival and possibilities for revision surgery. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:1237-1241, 2017.

A Framework for Measuring the Progress in Exoskeleton Skills in People with Complete Spinal Cord Injury.

For safe application of exoskeletons in people with spinal cord injury at home or in the community, it is required to have completed an exoskeleton training in which users learn to perform basic and advanced skills. So far, a framework to test exoskeleton skills is lacking. The aim of this study was to develop and test the hierarchy and reliability of a framework for measuring the progress in the ability to perform basic and advanced skills. Twelve participants with paraplegia were given twenty-four training sessions in 8 weeks with the Rewalk-exoskeleton. During the 2nd, 4th, and 6th training week the Intermediate-skills-test was performed consisting of 27 skills, measured in an hierarchical order of difficulty, until two skills were not achieved. When participants could walk independently, the Final-skills-test, consisting of 20 skills, was performed in the last training session. Each skill was performed at least two times with a maximum of three attempts. As a reliability measure the consistency was used, which was the number of skills performed the same in the first two attempts relative to the total number. Ten participants completed the training program. Their number of achieved intermediate skills was significantly different between the measurements XF2(2) = 12.36, p = 0.001. Post-hoc analysis revealed a significant increase in the median achieved intermediate skills from 4 [1-7] at the first to 10.5 [5-26] at the third Intermediate-skills-test. The rate of participants who achieved the intermediate skills decreased and the coefficient of reproducibility was 0.98. Eight participants met the criteria to perform the Final-skills-test. Their median number of successfully performed final skills was 16.5 [13-20] and 17 [14-19] skills in the first and second time. The overall consistency of >70% was achieved in the Intermediate-skills-test (73%) and the Final-skills-test (81%). Eight out of twelve participants experienced skin damage during the training, in four participants this resulted in missed training sessions. The framework proposed in this study measured the progress in performing basic and advanced exoskeleton skills during a training program. The hierarchical ordered skills-test could discriminate across participants' skill-level and the overall consistency was considered acceptable.

Safety of Osseointegrated Implants for Transfemoral Amputees: A Two-Center Prospective Cohort Study.

BACKGROUND: Osseointegrated implants are an alternative for prosthetic attachment for individuals unable to wear a socket following an amputation. The concept of an integrated metal implant communicating with the external environment raises substantial concern about the risk of ascending infection. We report on the safety of press-fit osseointegrated implants currently used in Australia and the Netherlands. METHODS: We prospectively recorded all adverse events in all patients with transfemoral amputation who were managed with an osseointegration implant system between 2009 and 2013 at two centers. The procedure was performed in two stages. A customized porous-coated implant was placed in the first stage, and a stoma was created in the second. Adverse events were categorized according to type (infection or "other") and severity. Infections were classified according to four grades of severity based on clinical and radiographic findings: (1) low-grade soft-tissue infection, (2) high-grade soft-tissue infection, (3) bone infection, and (4) septic implant failure. RESULTS: Eighty-six patients (ninety-one implants), twenty-five to eighty-one years of age, were included in the study and followed for a median of thirty-four months (range, twenty-four to seventy-one months). Thirty-one patients had an uneventful course with no complications; twenty-nine developed infection (all grade 1 or 2); and twenty-six did not develop infection but had one or more other complications requiring intervention, including stoma hypergranulation (seventeen patients), soft-tissue redundancy (fourteen), proximal femoral fracture (three), inadequate osseointegration leading to implant replacement (one), implant breakage (two), and breakage of the pin used as a fail-safe mechanism (twenty-five). CONCLUSIONS: Mild infection and irritation of the soft tissue in the skin-penetration area are common in transfemoral amputees who have an osseointegrated implant. These complications were successfully managed with simple measures. Severe infections resulting in septic implant loosening are rare. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial.

OBJECTIVE: To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. SETTING: The study was conducted at a level 1 trauma centre in the Netherlands. PARTICIPANTS: 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. INTERVENTIONS: Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. MEASUREMENTS: Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score--Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. RESULTS: The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI -1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. CONCLUSIONS: We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. TRIAL REGISTRATION NUMBERS: NCT00817128 and NTR 2090.

[Complex regional pain syndrome type 1: negating the myth]. / Complex regionaal pijnsyndroom type 1: de mythe ontkracht.

Complex regional pain syndrome type 1 (CRPS-1) was identified in the Netherlands more than 30 years ago, but since then the arguments supporting this diagnosis have become weaker. Incidence has decreased, it is often not possible to make a definite diagnosis, the pathophysiology remains unclear and treatments are extremely diverse. Since the patient group is so heterogeneous, it is often unclear exactly which patients should be included. Disuse due to immobilization can give an identical clinical picture, including the inflammatory parameters that are seen in CRPS-1. CRPS-1 following injury can be prevented with exercise, and incidence is declining dramatically. Taking these factors into consideration, we support the view that CRPS-1 is not an illness but rather a 'disuse syndrome' as a result of immobilization, or there may be a missed underlying diagnosis.

Acute phase complications following traumatic spinal cord injury in Dutch level 1 trauma centres.

OBJECTIVE: To assess the number and nature of complications during the acute phase following traumatic spinal cord injury and to explore the relationship between number of complications and length of hospital stay. DESIGN: Multi-centre prospective cohort study. PATIENTS: A total of 54 patients with traumatic spinal cord injury, referred to 3 level 1 trauma centres in The Netherlands. METHODS: The number and nature of complications were registered weekly from September 2009 to December 2011. RESULTS: A total of 32 patients (59%) had 1 or more medical complications. The most common complications were pressure ulcers (17 patients, 31%) and pulmonary complications (15 patients, 28%). PATIENTS with 3 or 4 complications had significantly (p < 0.01) longer hospital stays (58.5 [32.5] days) compared with those with 1 or 2 complications (33.1 [14.8] days) or no complications (21.5 [15.6] days). CONCLUSION: Complications, particularly pressure ulcers and pulmonary complications, occurred frequently during the acute phase following traumatic spinal cord injury. More complications were associated with longer hospital stays. Despite the existence of protocols, more attention is needed to prevent pressure ulcers during the acute phase following traumatic spinal cord injury for patients in The Netherlands.

Are pain-related fears mediators for reducing disability and pain in patients with complex regional pain syndrome type 1? An explorative analysis on pain exposure physical therapy.

OBJECTIVE: To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy. DESIGN: An explorative secondary analysis of a randomised controlled trial. PARTICIPANTS: Fifty-six patients with Complex Regional Pain Syndrome type 1. INTERVENTIONS: The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline. OUTCOME MEASURES: Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up. RESULTS: The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation. CONCLUSION: The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment. TRIAL REGISTRATION: International Clinical Trials Registry NCT00817128.