Routine versus on demand removal of the syndesmotic screw; A protocol for an international randomised controlled trial (RODEO-trial)

Background: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is removed after six to 12 weeks as it is thought to hamper ankle functional and to be a source of pain. Some studies however suggest this is only the case in a minority of patients. We therefore aim to investigate the effect of retaining the syndesmotic screw on functional outcome. Design: This is a pragmatic international multicentre randomised controlled trial in patients with an acute syndesmotic injury for which a metallic syndesmotic screw was placed. Patients will be randomised to either routine removal of the syndesmotic screw or removal on demand. Primary outcome is functional recovery at 12 months measured with the Olerud-Molander Score. Secondary outcomes are quality of life, pain and costs. In total 194 patients will be needed to demonstrate non-inferiority between the two interventions at 80% power and a significance level of 0.025 including 15% loss to follow-up. Discussion: If removal on demand of the syndesmotic screw is non-inferior to routine removal in terms of functional outcome, this will offer a strong argument to adopt this as standard practice of care. This means that patients will not have to undergo a secondary procedure, leading to less complications and subsequent lower costs. Trial registration: This study was registered at the Netherlands Trial Register (NTR5965), Clinicaltrials.gov (NCT02896998) on July 15th 2016

Differences between sporadic and MEN related primary hyperparathyroidism; clinical expression, preoperative workup, operative strategy and follow-up

<p>Background: Primary hyperparathyroidism (PHPT) is most commonly sporadic (sPHPT). However, sometimes PHPT develops as part of multiple endocrine neoplasia (MEN) type 1 or 2A. In all, parathyroidectomy is the only curative treatment. Nevertheless, there are important differences in clinical expression and treatment.</p><p>Methods: We analyzed a consecutive cohort of patients treated for sporadic, MEN1-related, and MEN2A-related PHPT and compared them regarding clinical and biochemical parameters, differences in preoperative workup, operative strategies, findings, and outcome.</p><p>Results: A total of 467 patients with sPHPT, 52 with MEN1- and 16 with MEN2A-related PHPT were analyzed. Patients with sPHPT were older, more often female and had higher preoperative calcium and parathyroid hormone levels, when compared with MEN1 and MEN2A patients. Minimally invasive parathyroidectomy (MIP) was performed in 367 of 467 sPHPT patients (79%). One abnormal parathyroid was found in 426 patients (91%). Two or more in 35 patients (7%). In six patients (1%) no abnormal parathyroid gland was retrieved. Of 52 MEN1 patients, eight (15%) underwent a MIP and 44 patients (85%) underwent conventional neck exploration (CNE); with resection of fewer than 3 1/2 enlarged glands in 21 patients (40%), subtotal parathyroidectomy (SPTX, 3-3 1/2 glands) in seventeen (33%) and total parathyroidectomy with autotransplantation (TPTX) in six (12%). Eleven patients (21%) had persistent disease, 29 (56%) recurrent PHPT and nine (17%) permanent hypoparathyroidism, mostly after TPTX. Of 16 MEN2A patients, six (38%) underwent MIP, four (25%) CNE and six (38%) selective resection of the enlarged gland(s) during total thyroidectomy. Three patients (19%) suffered from persistent PHPT and two (13%) developed recurrent disease.</p><p>Conclusions: Sporadic PHPT, MEN1-and MEN2A-related PHPT are three distinct entities as is reflected preoperatively by differences in gender, age at diagnosis and calcium and PTH levels. MEN2A patients are very similar to sPHPT with respect to operative approach and findings. MIP is the treatment of choice for both. MIP has low rates of persistent and recurrent PHPT and a low complication rate. The percentage of multiglandular disease and recurrences are significantly higher in MEN1 patients, demonstrating the need for a different approach. We advocate treating these patients with CNE and SPTX.</p>

Healthcare utilization and satisfaction with treatment before and after direct discharge from the Emergency Department of simple stable musculoskeletal injuries in the Netherlands

PURPOSE: To evaluate healthcare utilization and satisfaction with treatment before and after implementing direct discharge (DD) from the Emergency Department (ED) of patients with simple, stable musculoskeletal injuries. METHODS: Patients with simple, stable musculoskeletal injuries were included in two Dutch hospitals, both level-2 trauma centers: OLVG and Sint Antonius (SA), before (pre-DD-cohort) and after implementing DD (DD-cohort). With DD, no routine follow-up appointments are scheduled after the ED visit, supported by information leaflets, a smartphone application and a telephone helpline. Outcomes included: secondary healthcare utilization (follow-up appointments and X-ray/CT/MRI); satisfaction with treatment (scale 1-10); primary healthcare utilization (general practitioner (GP) or physiotherapist visited, yes/no). Linear regression was used to compare secondary healthcare utilization for all patients and per injury subgroup. Satisfaction and primary healthcare utilization were analyzed descriptively. RESULTS: A total of 2033 (OLVG = 1686; SA = 347) and 1616 (OLVG = 1396; SA = 220) patients were included in the pre-DD-cohort and DD-cohort, respectively. After DD, the mean number of follow-up appointments per patient reduced by 1.06 (1.13-0.99; p < 0.001) in OLVG and 1.07 (1.02-0.93; p < 0.001) in SA. Follow-up appointments reduced significantly for all injury subgroups. Mean number of follow-up X-rays per patient reduced by 0.17 in OLVG (p < 0.001) and 0.18 in SA (p < 0.001). Numbers of CT/MRI scans were low and comparable. In OLVG, mean satisfaction with treatment was 8.1 (pre-DD-cohort) versus 7.95 (DD-cohort), versus 7.75 in SA (DD-cohort only). In OLVG, 23.6% of pre-DD-cohort patients visited their GP, versus 26.1% in the DD-cohort, versus 13.3% in SA (DD-cohort only). Physiotherapist use was comparable. CONCLUSION: This study performed in a large population and additional hospital confirms earlier pilot results, i.e., that DD has the potential to effectively reduce healthcare utilization, while maintaining high levels of satisfaction. LEVEL OF EVIDENCE: II

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial

Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. clinicaltrials.gov Identifier: NCT0222582