Garcia-Rueda Maria Fernanda, Bohorquez-Penaranda Adriana Patricia, Gil-Laverde Jacky Fabian Armando, Aguilar-Sierra Francisco Javier, Mendoza-Pulido Camilo
Department of Orthopedics, Instituto Roosevelt, Bogotá, Colombia.
Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogotá, Colombia.
JMIR Res Protoc. 2022 Apr 14;11(4):e34576. doi: 10.2196/34576.
Acute treatment for distal radius fractures, the most frequent fractures in the pediatric population, represents a challenge to the orthopedic surgeon. Deciding on surgical restoration of the alignment or cast immobilization without reducing the fracture is a complex concern given the remodeling potential of bones in children. In addition, the lack of evidence-based safe boundaries of shortening and angulation, that will not jeopardize upper-extremity functionality in the future, further complicates this decision.
The authors aim to measure functional outcomes, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Physical Function v2.0 instrument. The authors hypothesize that outcomes will not be worse in children treated with cast immobilization in situ compared with those treated with closed reduction with or without percutaneous fixation. The authors also aim to compare the following as secondary outcomes: ulnar variance and fracture alignment in the sagittal and coronal planes, range of motion, pressure ulcers, pain control, radius osteotomy due to deformity, pseudoarthrosis cure, and remanipulation.
This is the protocol of a randomized noninferiority trial comparing upper-extremity functionality in children aged 5 to 10 years, after sustaining a distal radius fracture, treated with either cast immobilization in situ or closed reduction with or without fixation in a single orthopedic hospital. Functional follow-up is projected at 6 months, while clinical and radiographic follow-up will occur at 2 weeks, 3 months, and 9 months.
Recruitment commenced in July 2021. As of January 2022, 23 children have been randomized. Authors expect an average of 5 patients to be recruited monthly; therefore, recruitment and analysis should be complete by October 2024.
This experimental design that addresses upper-extremity functionality after cast immobilization in situ in children who have sustained a distal fracture of the radius may yield compelling information that could aid the clinician in deciding on the most suitable orthopedic treatment.
ClinicalTrials.gov NCT05008029; https://clinicaltrials.gov/ct2/show/NCT05008029.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34576.
桡骨远端骨折是儿科人群中最常见的骨折，其急性治疗对骨科医生来说是一项挑战。鉴于儿童骨骼的重塑潜力，决定手术恢复对线还是采用石膏固定而不进行骨折复位是一个复杂的问题。此外，缺乏基于证据的缩短和角度安全界限，而这些界限不会在未来危及上肢功能，这使得这一决策更加复杂。
作者旨在使用患者报告结局测量信息系统（PROMIS）儿科身体功能v2.0工具来测量功能结局。作者假设，与接受闭合复位（无论有无经皮固定）治疗的儿童相比，采用原位石膏固定治疗的儿童结局不会更差。作者还旨在比较以下次要结局：尺骨变异以及矢状面和冠状面的骨折对线、活动范围、压疮、疼痛控制、因畸形导致的桡骨截骨术、假关节治愈情况和再次手法复位。
这是一项随机非劣效性试验的方案，比较在单一骨科医院接受原位石膏固定或闭合复位（无论有无固定）治疗的5至10岁桡骨远端骨折儿童的上肢功能。预计功能随访时间为6个月，而临床和影像学随访将在2周、3个月和9个月时进行。
招募工作于2021年7月开始。截至2022年1月，已有23名儿童被随机分组。作者预计平均每月招募5名患者；因此，招募和分析工作应在2024年10月前完成。
这种针对桡骨远端骨折儿童原位石膏固定后上肢功能的实验设计可能会产生有说服力的信息，有助于临床医生决定最合适的骨科治疗方法。
ClinicalTrials.gov NCT05008029；https://clinicaltrials.gov/ct2/show/NCT05008029。
国际注册报告识别码（IRRID）：DERR1-10.2196/34576。
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