Clinical Research Directory

Advanced SPinal Innovations With Robotics and Enabling Technology Registry

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

The goal of this pilot hybrid type I efficacy/implementation trial is to assess a newly developed decision support tool patients, parents, and providers to use during surgical treatment decision making for neuromuscular scoliosis (NMS). Results from this pilot will inform the design of a future larger effectiveness trial of the decision support tool. Participants will either receive usual care or receive the decision support tool. Researchers will assess the decision made, decision quality, individual affective, cognitive, and behavioral effects, and feasibility and acceptability of tool use. They will also collect potential barriers and facilitators to implementation and feedback about the tool and study design to maximize likelihood of successful deployment of the tool into clinical practice and inform the design of a future trial. The outcomes measures will be used to inform potential effect size estimates to inform a future trial.

Kids With Iron Deficiency and Scoliosis

This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary * Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion. Secondary * Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. * Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex

Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)

Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis

OCTAGON trial is a randomized, double-blinded, parallel-group non-inferiority multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. 194 adolescents with idiopathic (major curve \> 45 degrees) or neuromuscular scoliosis (major curve \> 50 degrees) are enrolled for the OCTAGON trial comparing pooled human plasma (Octaplas, 10mL/kg, active management) vs. Plasmalyte (10 mL/kg, placebo) before incision as part of the normal intraoperative fluid therapy. Data is collected at baseline and at each follow-up until a minimum of 2-year follow-up. Outcomes Outcomes for the OCTAGON trial include 1) intraoperative blood loss (in mL, primary outcome) and the need for allogenic red blood cell infusion (percentage of patients). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection, neurologic deficit). Research questions and hypothesis Does prophylactic use of pooled human plasma decrease intraoperative blood loss in adolescents undergoing instrumented spinal fusion for scoliosis? We hypothesize that pooled human plasma will reduce intraoperative and total blood loss by 25% resulting in lower need for blood transfusion and fewer surgical site infections. Objectives To compare the effect of pooled human plasma vs. crystalloid fluids on intraoperative bleeding and total blood loss (drain output and hidden blood loss) in children undergoing posterior spinal fusion for AIS and NMS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI, deep surgical site infection, neurologic injury). Ethical aspects The PHP trial has been evaluated via European regulatory authority (EU CT: 2024-514857-31-00) and by Fimea (FIMEA/2024/006588). Informed consent is obtained from the parent(s). Results will be disseminated in high-quality peer-reviewed publications. The individual patient safety and high-quality management of fractures and scoliosis is a priority in this trial. The randomization can be opened at any stage of the treatment process. Based on the clinical decision the randomized treatment can be terminated and treatment provided accord-ing to clinical decision making even if results will be evaluated using the intention to treat princi-ple. Pain management will be prioritized in every clinical scenario and parental presence is always possible.

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: * What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? * Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: * Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years * Have clinical photos of their incision at 3 months, 1 year, and 2 years * Their photos will be assessed using the stony book scar evaluation scale * For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. * Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.