Background: Proximal femoral and/or pelvic osteotomies (PFPOs) can be indicated for a multitude of hip pathologies in (often asymptomatic) children, to prevent future hip problems. These procedures... Show moreBackground: Proximal femoral and/or pelvic osteotomies (PFPOs) can be indicated for a multitude of hip pathologies in (often asymptomatic) children, to prevent future hip problems. These procedures can result in significant blood loss. Tranexamic acid (TXA) is an antifibrinolytic agent routinely administered in adult trauma and joint reconstruction surgery to reduce blood loss. TXA is also registered for use in children and reported safe and beneficial for pediatric trauma, cardiac, and spinal surgery. However, for pediatric orthopedics, particularly for PFPOs, the available evidence is limited. Therefore, the current trial will investigate the potential reducing effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs.Methods: In this single-center, double-blind, randomized placebo-controlled trial, we aim to include 180 participants aged from 1 to 18 years undergoing PFPOs for any indication at our institution. Participants will be randomized to receive either TXA or placebo (saline) during anesthetic induction. The primary outcome is intraoperative estimated blood loss (mL/kg), which is determined gravimetrically. Secondary outcomes include the percentage of patients with excessive blood loss (>20 mL/kg), procedure time and hospital stay, and postoperative hemoglobin level changes.Discussion: This will be the first prospective study investigating the effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. Its results will help to determine whether it would be advisable to adopt preoperative TXA as a standard medication to minimize blood loss and prevent complications in this vulnerable population.Trial registration: EudraCT: 2022-002384-30. Prospectively registered on September 26, 2022. Show less
Brouwer, A.J.; Kempink, D.R.J.; Witte, P.B. de 2021
Purpose: Proximal femoral and/or pelvic osteotomies (PFPO) are associated with significant blood loss, which can be harmful, especially in paediatric patients. Therefore, considering methods to... Show morePurpose: Proximal femoral and/or pelvic osteotomies (PFPO) are associated with significant blood loss, which can be harmful, especially in paediatric patients. Therefore, considering methods to reduce blood loss is important. The purpose of this study was to examine the efficacy of tranexamic acid (TXA) in reducing intraoperative estimated blood loss (EBL) in paediatric patients undergoing a PFPO.Methods: Paediatric patients who had a PFPO between 2014 and 2019 were retrospectively reviewed. Outcome measures included patient demographics, TXA use (none, preoperative and/or intraoperative bolus, pump), EBL, transfusion rate and thromboembolic complications. Univariate and multivariate analyses were performed to assess associations between investigated outcome measures and EBL.Results: A total of 340 PFPO (263 patients) were included. Mean age at surgery was 8.0 years (so 4.3). In all, 269 patients received no TXA, 20 had a preoperative bolus, 43 had an intraoperative bolus and eight patients had other TXA regimes (preoperative and intraoperative bolus or pump). Overall, mean blood loss was 211 ml (SD 163). Multivariate analysis showed significant associations between higher EBL and higher age at surgery, male sex, higher body mass index and longer procedure time. There was a significant association between lower EBL and a preoperative TXA bolus: 66 ml (33%) less EBL compared with patients without TXA (95% confidence interval -129 to -4; p = 0.04). No thromboembolic complications were reported in any of the studied patients.Conclusion: Preoperative TXA administration is associated with a decreased EBL in PFPO. No thromboembolic events were reported. Administering TXA preoperatively appears to be effective in paediatric patients undergoing a PFPO. Show less
Siebelt, M.; Vos-Jakobs, S. de; Koenrades, N.; Nieuwenhoven, C.A.V. van; Oostenbrink, R.; Bramer, W.M.; ... ; Kempink, D.R.J. 2020
Background: A congenital forearm pseudarthrosis is a rare condition and is strongly associated with neurofibromatosis type 1. Several surgical techniques are described in the literature, but the... Show moreBackground: A congenital forearm pseudarthrosis is a rare condition and is strongly associated with neurofibromatosis type 1. Several surgical techniques are described in the literature, but the most optimal treatment strategy remains unclear. This systematic review aims to develop a treatment algorithm that may aid in clinical decision making. Methods: The PROSPERO registration number for this study was CRD42018099602 and adheres to the PRISMA guidelines for systematic reviews. Embase, MEDLINE, Cochrane Central, Web of Science, and Google Scholar databases were searched for published studies reporting on congenital forearm pseudarthrosis not related to other underlying pathologies like bacterial infection or fibrous dysplasia. Results were not restricted by date or study type, only English literature was allowed. Studies were assessed for quality using the critical appraisal checklist for case reports from the Joanna Briggs Institute. Patient characteristics, underlying disease, type of surgery, union rate, and functional outcome were extracted from included studies. Results: Of 829 studies identified, 47 were included in this review (17 case series and 30 case reports, a total of 84 cases). A one-bone forearm procedure showed highest union rates (92%), however, it results in loss of forearm rotation. Free vascularized fibula grafting showed high union rates (87%) and was related to good functional outcome of elbow flexion and forearm rotations. Other procedures showed disappointing outcomes. Conclusions: Congenital forearm pseudarthrosis is best treated with a free vascularized fibula grafting, a one-bone forearm procedure should be used as a salvage procedure. Evidence extracted from the case reports was sufficient to generate a treatment algorithm to be used in clinical pediatric practice. Show less
Geertsema, D.; Meinardi, J.E.; Kempink, D.R.J.; Fiocco, M.; Sande, M.A.J. van de 2019