A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

Background: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation. Methods/Design. The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36). Discussion. The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are treated with ORIF and additional stabilization with a hinged elbow fixator. Trial Registration. The trial is registered at the Netherlands Trial Register (NTR1996)

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial

Background. Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. Methods/Design. The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. Discussion. The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. Trial Registration. The trial is registered at the Netherlands Trial Register (NTR2025)

Value and patient appreciation of follow-up after endoscopic totally extraperitoneal (TEP) inguinal hernia repair

Purpose: There is some consensus on inguinal hernia surgery follow-up in research settings. However, consensus on regular follow-up is lacking. Therefore, patients and surgeons are unnecessarily burdened and not cost-efficient. Moreover, the purpose of follow-up is barely questioned. This study aims to evaluate follow-up after inguinal hernia repair and determine patient satisfaction. Methods: This prospective cohort study was executed in a high-volume specialized hernia clinic. All totally extraperitoneal (TEP) repair patients between July and October 2016 were included. Telephone follow-up was performed at 1 day, 6 weeks and 1 year postoperatively. One year postoperatively it was assessed whether patients visited other healthcare organizations, had remaining inguinal complaints, a Post-INguinal-repair-Questionnaire by telephone (PINQ-PHONE) was executed, and appreciation with follow-up was determined. Results: Respectively, 6 weeks and 1 year postoperatively, 138 (79.3%) and 130 (74.7%) of 174 included patients were reached. One year postoperatively 15 patients (11.5%) had remaining inguinal complaints, of which only four patients (3.1%) had not already reported their symptoms. Nineteen patients (14.6%) presented with self-reported complaints between 6 weeks and 1 year, and no patients went to other hospitals. Respectively, 107 (82.3%), 61 (46.9%) and 117 (90.0%) patients considered follow-up useful at 6 weeks, 1 year and in general. One hundred nineteen patients (91.5%) preferred telephone follow-up to outpatient clinic appointments. Conclusion: TEP patients value a telephone follow-up time-point, however, long-term follow-up is not considered useful. Patients report postoperative complaints themselves, therefore performing follow-up serves no clinical purpose. The purpose of follow-up is patient satisfaction and registration for quality objectives

Athletes with inguinal disruption benefit from endoscopic totally extraperitoneal (TEP) repair

Purpose: Inguinal disruption, a common condition in athletes, is a diagnostic and therapeutic challenge. The aim of this study was to evaluate the effect of endoscopic totally extraperitoneal (TEP) repair in athletes with inguinal disruption, selected through a multidisciplinary, systematic work-up. Methods: An observational, prospective cohort study was conducted in 32 athletes with inguinal disruption. Athletes were assessed by a sports medicine physician, radiologist and hernia surgeon and underwent subsequent endoscopic TEP repair with placement of polypropylene mesh. The primary outcome was pain reduction during exercise on the numeric rating scale (NRS) 3 months postoperatively. Secondary outcomes were sports resumption, physical functioning and long-term pain intensity. Patients were assessed preoperatively, 3 months postoperatively and after a median follow-up of 19 months. Results: Follow-up was completed in 30 patients (94%). The median pain score decreased from 8 [interquartile range (IQR) 7–8] preoperatively to 2 (IQR 0–5) 3 months postoperatively (p < 0.001). At long-term follow-up, the median pain score was 0 (IQR 0–3) (p < 0.001). At 3 months, 60% of patients were able to complete a full training and match. The median intensity of sport was 50% (IQR 20–70) preoperatively, 95% (IQR 70–100) 3 months postoperatively (p < 0.001), and 100% (IQR 90–100) at long-term follow-up (p < 0.001). The median frequency of sport was 4 (IQR 3–5) times per week before development of symptoms and 3 (IQR 3–4) times per week 3 months postoperatively (p = 0.025). Three months postoperatively, improvement was shown on all physical functioning subscales. Conclusions: Athletes with inguinal disruption, selected through a multidisciplinary, systematic work-up, benefit from TEP repair

Isolated hip fracture care in an inclusive trauma system : A trauma system wide evaluation

Introduction: Elderly patients with a hip fracture represent a large proportion of the trauma population; however, little is known about outcome differences between different levels of trauma care for these patients. The aim of this study is to analyse the outcome of trauma care in patients with a hip fracture within our inclusive trauma system. Materials and methods: Retrospective cohort study. Data were collected from the electronic patient documentation of patients, with an isolated hip fracture (aged ≥60), admitted to a level I or level II trauma centre between January 2008 and December 2012. Main outcomes were time to operative treatment, complications, mortality, and secondary surgical intervention rate. Results: A total of 204 (level I) and 1425 (level II) patients were admitted. Significantly more ASA4 patients, by the American Society of Anesthesiologists (ASA) classification, were treated at the level I trauma centre. At the level II trauma centre, median time to surgical treatment was shorter (0 days; IQR 0-1 vs 1 day; IQR 1-2; P <. 0.001), which was mainly influenced by postponement due to lack of operation room availability (14%, n = 28) and co-morbidities (13%, n = 26) present at the level I trauma centre. At the level II trauma centre, hospital stay was shorter (9 vs 11 days; P <. 0.001) and the complication rate was lower (41%; n = 590 vs 53%; n = 108; P = 0.002), as was mortality (4%; n = 54 vs 7%; n = 15; P = 0.018). Secondary surgical intervention was performed less often at the level II trauma centre (6%; n = 91vs 12%; n = 24; P = 0.005). However, no differences in secondary surgical procedures due to inadequate postoperative outcome or implant failure were observed. Conclusion and relevance: The clinical pathway and the large volume of patients at the level II centre resulted in earlier surgical intervention, lower overall complication and mortality rate, and a shorter length of stay. Therefore, the elderly patient with a hip fracture should ideally be treated in the large-volume level II hospital with a pre-established clinical pathway. However, complex patients requiring specific care that can only be provided at the level I trauma centre may be treated there with similar operative results

Three-month results of the effect of Ultrapro or Prolene mesh on post-operative pain and well-being following endoscopic totally extraperitoneal hernia repair (TULP trial)

BACKGROUND: Recurrence rates after inguinal hernia repair have been reduced to a few per cent, since mesh repair has become standard of care. Lightweight meshes reduce post-operative pain and stiffness in open anterior repair, but for endoscopic repair, the discussion about this benefit is ongoing. This study was done to analyse the effects of lightweight mesh versus heavyweight mesh following endoscopic totally extraperitoneal (TEP) hernia repair. METHODS: In a single-centre double-blindly randomized clinical trial, 950 patients with unilateral primary inguinal hernia were randomized to undergo endoscopic TEP using either an Ultrapro(®) or a Prolene(®) mesh. Data were collected by validated questionnaires at day 1, day 7, after 6 weeks and after 3 months, and clinical assessment was performed after 3 months. The presence of groin pain after 3 months, defined as an NRS score >3, was evaluated as the primary outcome measure. Secondary outcomes were foreign body feeling and the impact of pain and foreign body feeling on daily activities. RESULTS: At 3-month follow-up, the incidence of pain (NRS 4-10) was 2 versus 0.9 % in the lightweight and heavyweight mesh group, respectively (p = 0.17). Pain interfered with daily activities in 1.7 % of the lightweight and 1.5 % of heavyweight group. In the lightweight group, 20 % of patients reported a foreign body feeling versus 18 % in the heavyweight group (p = 0.62). No differences between the groups were observed regarding time to return to work, interference with sports and sexual activities, testicular pain and ejaculatory pain. Severe preoperative pain (OR 2.01, 95 % CI 1.21-3.35, p = 0.01) was the only independent predictor of any post-operative pain after 3 months. CONCLUSION: Three months after TEP inguinal repair, there were no significant differences between lightweight and heavyweight mesh use regarding the incidence of pain, foreign body feeling or any other endpoint

Pain after totally extraperitoneal (TEP) hernia repair might fade out within a year

Background: The incidence of chronic pain after endoscopic hernia repair varies between 1 and 16 %. Studies regarding the course of pain in time after the operation are scarce. Methods: 473 male patients ≥18 years of age, scheduled for totally extraperitoneal (TEP) hernia repair (Prolene® mesh) between March 2010 and August 2012 were requested to record pain symptoms preoperative, and 1 day, 1 week, 6 weeks, 3 months and 1 year postoperatively and visit the outpatient department 3 months and 1 year postoperatively for a standardized interview and physical examination. Results: Preoperatively, 25 % (n = 114) of the patients had moderate-to-severe pain (NRS 4–10). Six weeks postoperatively, 3 % (n = 12) of the patients still experienced moderate-to-severe pain. Three months after TEP, only 3 patients (0.6 %) had moderate-to-severe pain, while 83 patients (18 %) experienced mild pain. One year after TEP, 39 patients experienced mild pain (8 %) and 3 patients moderate pain (0.7 %), no patients experienced severe pain after 1 year. Patients with moderate-to-severe pain preoperatively had a higher risk of pain persisting until 3 months and 1 year postoperatively (p = 0.03). In most patients who had pain 3 months postoperatively and were pain-free 1 year after TEP, pain ‘faded out’ at 4–6 months postoperatively. Two patients had a not-painful recurrent hernia, diagnosed 2 and 5 months after TEP repair. Conclusion: Moderate-to-severe pain after TEP hernia repair is self-limiting, with less than 1 % of the patients reporting moderate pain 1 year postoperatively

Three-month results of the effect of Ultrapro or Prolene mesh on post-operative pain and well-being following endoscopic totally extraperitoneal hernia repair (TULP trial)

BACKGROUND: Recurrence rates after inguinal hernia repair have been reduced to a few per cent, since mesh repair has become standard of care. Lightweight meshes reduce post-operative pain and stiffness in open anterior repair, but for endoscopic repair, the discussion about this benefit is ongoing. This study was done to analyse the effects of lightweight mesh versus heavyweight mesh following endoscopic totally extraperitoneal (TEP) hernia repair. METHODS: In a single-centre double-blindly randomized clinical trial, 950 patients with unilateral primary inguinal hernia were randomized to undergo endoscopic TEP using either an Ultrapro(®) or a Prolene(®) mesh. Data were collected by validated questionnaires at day 1, day 7, after 6 weeks and after 3 months, and clinical assessment was performed after 3 months. The presence of groin pain after 3 months, defined as an NRS score >3, was evaluated as the primary outcome measure. Secondary outcomes were foreign body feeling and the impact of pain and foreign body feeling on daily activities. RESULTS: At 3-month follow-up, the incidence of pain (NRS 4-10) was 2 versus 0.9 % in the lightweight and heavyweight mesh group, respectively (p = 0.17). Pain interfered with daily activities in 1.7 % of the lightweight and 1.5 % of heavyweight group. In the lightweight group, 20 % of patients reported a foreign body feeling versus 18 % in the heavyweight group (p = 0.62). No differences between the groups were observed regarding time to return to work, interference with sports and sexual activities, testicular pain and ejaculatory pain. Severe preoperative pain (OR 2.01, 95 % CI 1.21-3.35, p = 0.01) was the only independent predictor of any post-operative pain after 3 months. CONCLUSION: Three months after TEP inguinal repair, there were no significant differences between lightweight and heavyweight mesh use regarding the incidence of pain, foreign body feeling or any other endpoint