Wrist Injuries

腕部损伤
  • 文章类型: Journal Article
    结论:桡尺远侧关节(DRUJ)对腕部和前臂的稳定性和功能至关重要。骨形态是可变的并且提供很小的稳定性。融合的软组织复合体是主要的稳定剂;然而,每个组成部分的贡献还有待阐明。越来越清楚的是,桡骨远端骨折的解剖固定恢复了DRUJ的稳定性,避免了额外的DRUJ稳定的需要。这篇综述将描述DRUJ的解剖学和生物力学,并讨论损伤模式,治疗,和临床结果。
    CONCLUSIONS: The distal radioulnar joint (DRUJ) is vital to the stability and function of the wrist and forearm. The osseous morphology is variable and provides little stability. A complex of confluent soft tissues is the primary stabilizer; however, the contribution of each component has yet to be elucidated. It has become increasingly clear that the anatomic fixation of distal radius fractures restores DRUJ stability, obviating the need for additional DRUJ stabilization. This review will describe the anatomy and biomechanics of the DRUJ and discuss injury patterns, treatments, and clinical results.
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  • 文章类型: Journal Article
    目的:本研究旨在使用单阶段评估切开复位内固定(ORIF)治疗慢性骨周脱位的结果,两阶段,和打捞程序。该研究还将这些方法相互比较,并与现有文献的结果进行比较。
    方法:将2013年至2019年的15例慢性牙周炎损伤患者纳入研究。术前和术后评估使用平片进行,选择性地进行CT扫描以进行详细的形态和断裂模式分析。在患者中,13接受ORIF,而2人接受了打捞程序。在ORIF案件中,对4例患者进行了单阶段手术,以及9例患者的两阶段手术。外部固定器,包括单侧单平面外固定器(UUEF)和双侧单平面外固定器(BUEF),分别应用于5名和4名患者,分别。多年来,我们治疗慢性perilunate损伤的方法不断发展。我们从单阶段ORIF开始,然后逐步进行两个阶段的手术,最初使用外部固定器作为仅在radial侧施加的腕骨撑开器,最后使用在radi侧和尺侧的外部固定器进行双侧腕骨撑开。
    结果:在15名患者中,3人失去了随访。其中,一个接受了四角融合,而其余两人有UUEF。受伤和手术之间的平均时间间隔为3.60个月。术后平均肩胛骨角度52.46°,在两名患者中观察到负射线角(表明屈曲),而其他人则显示为正角度(表示延伸)。2例显示舟骨骨不连和血管坏死(AVN),而一个病例出现了lunateAVN。在4例和2例患者中观察到中腕和放射性腕关节关节炎,分别。使用Mayo的腕部评分对两阶段BUEF病例进行了评估,对UUEF和单阶段手术进行了评估。
    结论:与UUEF相比,利用BUEF进行阶段性减少,然后进行开放减少已证明效果更好,单阶段开放还原和打捞程序。
    方法:4.
    OBJECTIVE: This study aims to evaluate the outcomes of open reduction and internal fixation (ORIF) for chronic perilunate dislocations using single-stage, two-stage, and salvage procedures. The study also compares these approaches with each other and with results from existing literature.
    METHODS: A total of 15 patients with chronic perilunate injuries from 2013 to 2019 were included in the study. Pre-operative and post-operative assessments were conducted using plain radiographs, with CT scans performed selectively for detailed morphology and fracture pattern analysis. Among the patients, 13 underwent ORIF, while 2 underwent salvage procedures. Among the ORIF cases, single-stage procedures were performed in 4 patients, and two-stage procedures in 9 patients. External fixators, including unilateral uniplanar external fixators (UUEF) and bilateral uniplanar external fixators (BUEF), were applied in 5 and 4 patients, respectively. Our methodology of treating chronic perilunate injuries has evolved over the years. We started with single stage ORIF then graduated to a two staged procedure initially using a external fixator as a carpal distractor applied only on the radial side and finally settling down with bilateral carpal distraction using external fixators both on the radial and ulnar sides.
    RESULTS: Among the 15 patients, 3 were lost to follow-up. Of these, one underwent four-corner fusion, while the remaining two had UUEF. The mean time interval between injury and surgery was 3.60 months. The post-operative mean scapholunate angle measured 52.46°, with a negative radio-lunate angle (indicating flexion) observed in two patients, while others showed a positive angle (indicating extension). Two cases exhibited nonunion and avascular necrosis (AVN) of the scaphoid, while one case presented with lunate AVN. Mid-carpal and radio-carpal arthritis was observed in 4 and 2 patients, respectively. Functional outcomes were evaluated using Mayo\'s wrist score categorized as good for two-stage BUEF cases and satisfactory for UUEF and single-stage procedures.
    CONCLUSIONS: Staged reduction utilizing the BUEF followed by open reduction has demonstrated superior outcomes when compared to UUEF, single-stage open reduction and salvage procedures.
    METHODS: 4.
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  • 文章类型: Journal Article
    由于儿童骨骼的独特特征及其不同的损伤模式,小儿腕关节损伤提出了独特的诊断挑战。动态发展的手腕,以骨龄和骨化中心出现的变化为标志,对于评估生长和识别潜在病理至关重要。骨骼组成,富含软骨,使骨骼相对更弱但更有弹性,影响他们对骨折的敏感性。前臂骨折显示受扭转力影响的不同模式。舟骨骨折,在儿童中不常见,不同于成年人。在儿科人群中,像Madelung的畸形和尺骨变异是更常见的腕关节疾病。此外,肌腱损伤和三角纤维软骨复合体病变患者的症状缺乏和非特异性可能在诊断上具有挑战性.本文回顾了小儿腕部损伤,强调骨化模式,常见骨折类型,和发育变体。掌握小儿腕部发育和相关病理中的这些复杂性对于精确诊断和治疗至关重要。
    Pediatric wrist injuries pose unique diagnostic challenges due to distinct bone characteristics in children and their diverse injury patterns. The dynamic development of the wrist, marked by changes in bone age and emerging ossification centers, is crucial to evaluate growth and identify potential pathologies. The skeletal composition, rich in cartilage, renders bones relatively weaker yet more elastic, impacting their susceptibility to fracture. Forearm fractures display diverse patterns influenced by torsional forces. Scaphoid fractures, less common in children, differ from those in adults. Conditions like Madelung\'s deformity and ulnar variance are more common wrist disorders in the pediatric population. In addition, the scarcity and nonspecificity of symptoms in those with tendon injuries and triangular fibrocartilage complex lesions can be diagnostically challenging. This article reviews pediatric wrist injuries, emphasizing ossification patterns, common fracture types, and developmental variants. Grasping these complexities in pediatric wrist development and associated pathologies is essential for precise diagnosis and treatment.
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  • 文章类型: Journal Article
    背景:在低收入和中等收入国家,职业性手和手腕受伤(OHWIs)占与工作有关的事故的25%。在哥伦比亚,2021年发生了超过50万起职业事故,尽管这一比率在2020年和2021年下降到不到5%,但至少有四分之一的事故涉及手或手腕受伤。
    目的:描述在哥伦比亚二级医院急诊室看到的工人中的OHWIs。
    方法:一项观察性研究使用来自经历OHWIs并在二级医院就诊的工人的数据进行,六月之间,2020年5月,2021年。OHWIs的总体频率,以及它们按社会人口统计的分布,临床,和职业变量,被描述。此外,性别之间的关联模式,解剖区域(手指,手,手腕),和工作类型进行了对应分析(CA)。
    结果:有2.101名工人因职业事故接受治疗,423例(20.3%)是OHWIs,主要影响男性(93.9%),中位年龄为31岁,主要在采矿业工作(75.9%)。OHWIs在右上肢更为常见(55.3%),包括不同类型的损伤,如挫伤(42.1%),裂伤(27.9%),骨折(18.7%),挤压伤(15.6%)。他们主要影响指骨(95.2%),尤其是第一个手指(25.7%)。CA显示受伤的解剖区域与工人的工作之间的关联在男性和女性中有所不同(解释方差>90%)。
    结论:昆迪纳马卡遭受职业事故的五分之一工人,哥伦比亚有一个OHWI,主要影响从事采矿的男性。这种职业特征很可能会导致长期康复,和永久性的功能限制。我们的结果可能有助于调整集群风险组的预防措施。
    BACKGROUND: Occupational hand and wrist injuries (OHWIs) account for 25% of work-related accidents in low- and middle-income countries. In Colombia, more than 500000 occupational accidents occurred in 2021, and although the rate declined to less than 5% in 2020 and 2021, at least one in four accidents involved a hand or wrist injury.
    OBJECTIVE: To describe the OHWIs in workers seen at the emergency room at a second-level hospital in Colombia.
    METHODS: An observational study was performed using data from workers who experienced OHWIs and attended a second-level hospital, between June, 2020 and May, 2021. The overall frequency of OHWIs, as well as their distribution by sociodemographic, clinical, and occupational variables, are described. Furthermore, association patterns between sex, anatomical area (fingers, hand, wrist), and type of job were analyzed by correspondence analysis (CA).
    RESULTS: There were 2.101 workers treated for occupational accidents, 423 (20.3%) were cases of OHWIs, which mainly affected men (93.9%) with a median age of 31 years and who worked mainly in mining (75.9%). OHWIs were more common in the right upper extremity (55.3%) and comprised different types of injuries, such as contusion (42.1%), laceration (27.9%), fracture (18.7%), and crush injury (15.6%). They primarily affected the phalanges (95.2%), especially those of the first finger (25.7%). The CAs showed associations between the injured anatomical area and the worker\'s job that differed in men and women (explained variance > 90%).
    CONCLUSIONS: One out of five workers who suffered occupational accidents in Cundinamarca, Columbia had an OHWI, affecting mainly males employed in mining. This occupational profile is likely to lead to prolonged rehabilitation, and permanent functional limitations. Our results might be useful for adjusting preventive measures in cluster risk groups.
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  • 文章类型: Journal Article
    背景:为了在三角纤维软骨复合体(TFCC)损伤后恢复远端的尺右臂关节稳定性,中央凹修复手术可能是必要的。手术后康复是为了恢复腕部和手部功能;然而,目前尚无普遍接受或确定的康复方案.这项研究的目的是调查手和腕部外科医生在TFCC中央凹修复手术后推荐的术后康复方案。方法:邀请澳大利亚的手和腕部外科医生完成包含10个问题的描述性调查。问题包括腕部和前臂固定的临床建议,TFCC破裂的运动范围(ROM)锻炼时间和外科医生经验。描述性统计和组间(TFCC破裂与计算了无破裂)比较(Pearson'sChi2)。结果:31名外科医生完成了调查。术后固定的建议范围从“不需要”到8周(模式6周)。腕部和前臂ROM开始时间为\'立即\'至\'晚于8周\'(模式6周)。最推荐的矫形器是“糖通”(57%)。37%(37%)报告了手术后再破裂的经验。结论:虽然外科医生的建议各不相同,大多数人建议在4至6周的时间范围内进行固定和ROM锻炼。建议进行其他临床研究,以评估术后康复决策是否会影响患者的预后。证据等级:V级(治疗)。
    Background: To restore distal radioulnar joint stability following injury to the Triangular Fibrocartilage Complex (TFCC), foveal repair surgery may be necessary. Post-surgery rehabilitation is prescribed to restore wrist and hand function; however, no universally accepted or definitive rehabilitation protocol currently exists. The aim of this study was to survey hand and wrist surgeons regarding their recommended postoperative rehabilitation protocols following TFCC foveal repair surgery. Methods: Australian hand and wrist surgeons were invited to complete a descriptive survey containing 10 questions. Questions included clinical recommendations for wrist and forearm immobilisation, range of motion (ROM) exercise timeframes and surgeon experience of TFCC rupture. Descriptive statistics and between-group (TFCC rupture vs. no-rupture) comparisons (Pearson\'s Chi2) were calculated. Results: Thirty-one surgeons completed the survey. Recommendations for post-surgery immobilisation ranged from \'not required\' to 8 weeks (mode 6 weeks). Wrist and forearm ROM commencement time ranged from \'immediately\' to \'later than 8 weeks\' (mode 6 weeks). The most recommended orthosis was a \'sugar-tong\' (57%). Thirty-seven percent (37%) reported experience of post-surgery re-rupture. Conclusions: While surgeon recommendations varied, the majority recommended 4- to 6-week timeframe for immobilisation and ROM exercise commencement. Additional clinical research is recommended to evaluate whether postoperative rehabilitation decisions influence patient outcomes. Level of Evidence: Level V (Therapeutic).
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  • 文章类型: Journal Article
    背景:骨周骨折脱位通常与发生创伤后关节炎的高风险相关。目前的研究表明,在中期随访期间,关节炎的放射学征象似乎与功能评分不一致。这项研究的目的是在7年的中期随访中评估外伤性关节脱位(PLD)和骨折脱位后创伤后关节炎的发生和腕关节功能。方法:我们报告了通过背侧韧带修复的背侧入路切开复位内固定治疗PLD或骨折脱位的17个手腕的临床和放射学结果。使用简短版本的手臂快速残疾评估功能结果,肩和手问卷(QuickDASH),患者评估腕部评估问卷(PRWE)和Mayo腕部评分(MWS)。使用Herzberg放射学评分图评估X射线照片的结果。结果:MWS表现为5优,五好,5个成绩一般,2个成绩差,平均得分为81%。使用Herzberg分类的放射学分析显示65%的病例中腕和/或radi腕关节关节炎,59%的月肉塌陷和53%的平均尺骨易位率增加。并发症包括1例月骨坏死和1例需要翻修手术的3期肩胛骨晚期塌陷。结论:虽然临床和功能结果在中期随访是有利的,放射学评估显示骨关节炎(OA)的进展。需要进一步的研究来完善治疗策略并调查影响OA发展的因素。证据级别:IV级(治疗)。
    Background: Perilunate fracture-dislocations are frequently associated with a high risk of developing post-traumatic arthritis. Current studies indicate that during mid-term follow-ups, radiological signs of arthritis do not appear to correspond with functional score. The aim of this study was to assess the occurrence of posttraumatic arthritis and the wrist function after perilunate dislocations (PLD) and fracture dislocations at a mid-term follow-up of 7 years. Methods: We report the clinical and radiological outcomes of 17 wrists treated for PLD or fracture-dislocation by open reduction and internal fixation through a dorsal approach with dorsal ligament repair. Functional outcomes were evaluated using the short version of the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), the Patient-Rated Wrist Evaluation questionnaire (PRWE) and the Mayo Wrist Score (MWS). Results of radiographs were assessed using the Herzberg Radiological Scoring Chart. Results: The MWS showed five excellent, five good, five fair and two poor results with an average score of 81%. Radiological analysis using the Herzberg classification revealed midcarpal and/or radiocarpal arthritis in 65% of cases, lunate collapse in 59% and an increase in the mean ulnar translocation ratio in 53% of the cases. Complications included one case of lunate osteonecrosis and one case of stage 3 scapholunate advanced collapse that required revision surgery. Conclusions: Although the clinical and functional outcomes are favourable at mid-term follow-up, radiological evaluation shows a progression towards osteoarthritis (OA). Further research is warranted to refine treatment strategies and investigate factors influencing the development of OA. Level of Evidence: Level IV (Therapeutic).
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  • 文章类型: Case Reports
    背景:由于挤压机制引起的高能创伤后腕部或前臂远端截肢与复杂的组织缺损有关,正在修理,重建具有挑战性。鉴于这种打捞的难度,不幸的是,患者的翻修截肢率高。然而,据报道,重建成功的患者的生活质量更高.在这里,我们描述了使用股前外侧皮瓣(ALT)从粉碎机制进行创伤性截肢后的功能性手抢救的血运重建和重建方法。
    方法:2016年10月至2023年10月对所有接受单阶段紧急清创的患者进行了回顾性研究,血运重建,在高能量挤压伤继发的腕部或前臂远端截肢后,使用ALT覆盖软组织。检查术前复杂肢体挽救评分的图表,术中细节,包括哪些结构受伤和重建方法,和术后数据,如随访时间,结果,和并发症。
    结果:11例患者符合纳入标准,平均年龄为35.5(21-49)岁。皮肤软组织缺损的平均大小为17.3×8cm(范围,长度:13-25厘米,宽度:6-13厘米),所有病例都对下面的骨骼有相关的损伤,神经,和血管。用于重建的ALT皮瓣的平均大小为19.2×9.8cm(范围,长度:14-27厘米,宽度:7-15厘米)。所有患者都有再植肢体的存活。一名患者出现部分皮瓣坏死,需要二次清创和皮肤移植。9例患者愈合,无需任何额外的清创程序。患者平均随访24.6(12-38)个月。所有患者均达到满意的功能恢复,符合陈氏标准的II至III级。
    结论:对于外伤性腕部挤压截肢伴周围软组织损伤的患者,彻底清创,血运重建,截肢的重建可以使用ALT在一个阶段进行。提出了来自两个机构的协议化方法,证明创伤肢体的生存率提高,并发症减少,患者的长期预后得到改善。
    BACKGROUND: Amputation of the wrist or distal forearm after high-energy trauma due to a crushing mechanism is associated with complex tissue defects, making repair, and reconstruction challenging. Given the difficulty of this type of salvage, patients unfortunately experience a high revision amputation rate. However, a higher quality of life has been reported in patients with successful reconstructions. Herein, we described a protocolized approach for revascularization and reconstruction for functional hand salvage after traumatic amputation from a crushing mechanism using an anterolateral thigh flap (ALT).
    METHODS: A retrospective review was performed between October 2016 and October 2023 for all patients who underwent single-stage emergent debridement, revascularization, and soft tissue coverage using the ALT after amputation at the level of the wrist or distal forearm secondary to high-energy crush injury. Charts were reviewed for the preoperative Mangled Extremity Salvage Score, intraoperative details including what structures were injured and the reconstructive method performed, and postoperative data such as follow-up duration, outcomes, and complications.
    RESULTS: Eleven patients met the inclusion criteria with an average age of 35.5 (21-49) years old. The average size of the skin soft tissue defects was 17.3 × 8 cm (range, length: 13-25 cm, width: 6-13 cm), and all cases had associated injury to the underlying bone, nerves, and blood vessels. The average size of the ALT flap used for reconstruction was 19.2 × 9.8 cm (range, length: 14-27 cm, width: 7-15 cm). All patients had survival of the replanted limb. One patient experienced partial flap necrosis that required secondary debridement and skin graft. Nine patients healed without requiring any additional debridement procedures. Patient follow-up averaged 24.6 (12-38) months. All patients achieved satisfactory functional recovery with Grade II to III of Chen\'s criteria.
    CONCLUSIONS: For patients with traumatic crush amputation to the wrist with surrounding soft tissue injury, thorough debridement, revascularization, and reconstruction of amputated limbs can be performed in a single stage using the ALT. A protocolized approach from two institutions is presented, demonstrating improved survival and reduced complications of the traumatized limb with improved long-term patient outcomes.
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  • 文章类型: Journal Article
    手和手腕的软骨损伤可能会使运动员衰弱。鉴于存在广泛的症状学,诊断很困难。病史和体格检查对于实现正确诊断至关重要,先进的成像也可以为临床医生提供有益的帮助。TFCC损伤和尺骨嵌塞综合征是手和腕疼痛运动员中最常见的疾病。这些损伤的治疗最初是非手术的,但是精英运动员可能会选择绕过非手术治疗,以更早地恢复运动。手术治疗各不相同,但可以包括开放和关节镜方法。临床医生应根据比赛水平为每个运动员制定治疗计划,运动类型,个人偏好和目标。
    Cartilage injuries of the hand and wrist can be debilitating in the athlete. Diagnosis is difficult given the broad spectrum of presenting symptomatology. History and physical examination is crucial to achieve the correct diagnosis, and advanced imaging can offer helpful assistance to the clinician as well. TFCC injuries and ulnar impaction syndrome are among the most common conditions in athletes with hand and wrist pain. Treatment of these injuries is initially nonoperative, but elite athletes may elect to bypass nonoperative treatment in favor of earlier return to sport. Surgical treatment varies but can include open and arthroscopic methods. The clinician should tailor treatment plans to each athlete based on level of competition, type of sport, and individual preferences and goals.
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  • 文章类型: Journal Article
    目的:通过比较有和没有舟骨骨折的患者在伸出的手跌倒后腕关节的放射学参数,研究解剖变异对舟骨骨折机制的影响。
    方法:对有舟骨骨折(第1组,n=169)和无舟骨骨折(第2组,n=188)患者的X线片进行横断面比较回顾性分析。测量形态测量数据,包括径向倾角(RI),径向高度(RH),尺骨方差(UV),腕高(CH)比,修订腕部高度(RCH)比率和桡骨远端手掌倾斜(PT)。使用受试者工作特征(ROC)曲线分析来评估每个变量的诊断性能,具有统计学上的显着差异。
    结果:平均RI和PT度以及RH长度在统计学上明显更高,与第2组相比,第1组的平均紫外线较低。在CH比率和RCH比率方面,两组之间没有差异。用ROC曲线分析,将比值比最高的截止值确定为RH(截止值=10.77mm,OR=21.886)。
    结论:尽管RI较高,RH,与非骨折组相比,舟骨骨折组的PT值和更多的尺骨负方差,ROC曲线分析显示,仅RH增加可被认为是伸展手跌倒后舟骨骨折的可能危险因素。
    背景:射线照片,危险因素,舟骨骨折,手腕形态。
    OBJECTIVE: To investigate the effects of anatomical variations on the mechanism of scaphoid fracture by comparing the radiologic parameters of the wrist of patients with and without scaphoid fracture after a fall on an outstretched hand.
    METHODS: Cross-sectional comparative retrospective analysis of radiographs of patients with (Group 1, n=169) and without scaphoid fracture (Group 2, n=188). Morphometric data were measured including radial inclination (RI), radial height (RH), ulnar variance (UV), carpal height (CH) ratio, revised carpal height (RCH) ratio and palmar tilt of the distal radius (PT). Receiver operating characteristics (ROC) curve analysis was used to assess the diagnostic performance for each variable with statistically significant difference.
    RESULTS: The mean RI and PT degrees and RH length were statistically significantly higher, and the mean UV was lower in Group 1 compared to Group 2. No difference was determined between the groups with respect to the CH ratio and RCH ratio. With ROC curve analysis, the cut-off value with the highest odds ratio was determined as RH (Cut-off value=10.77 mm, OR=21.886).
    CONCLUSIONS: Although higher RI, RH, PT values and more negative ulnar variance were observed in the scaphoid fracture group compared to the non-fracture group, ROC curve analysis showed that only increased RH can be considered as a possible risk factor for scaphoid fractures after fall on an outstretched hand.
    BACKGROUND: radiographs, risk factor, scaphoid fracture, wrist morphology.
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  • 文章类型: Journal Article
    背景:儿童前臂远端移位骨折的治疗传统上是闭合复位和销钉固定,尽管它们可能在没有功能损害的情况下无需手术即可治愈和重塑。尚未发表随机对照试验,比较非手术或手术治疗移位的儿科前臂远端骨折后患者报告的功能结果。
    方法:一项多中心非劣效性随机对照试验。4-10岁前臂远端骨折移位的儿童将被纳入。如果值班整形外科医生发现手术干预的迹象。他们将被平均分配给非手术治疗(干预)或外科医生选择的手术治疗(比较)。随访时间为4周和3、6和12个月。主要结果是12个月QuickDASH评分的组间差异。我们将需要40名患者的样本,以显示80%功率的15分差异。
    结论:本试验的结果可能会改变我们对小儿前臂远端骨折愈合潜力的认识。如果显示非手术治疗的非劣效性,结果可能有助于减少未来对儿童的手术,反过来,他们可以在没有手术风险和心理负担的情况下接受治疗。
    背景:www.
    结果:gov(ID:NCT05736068)。登记日期:2023年2月17日。
    BACKGROUND: Treatment of displaced distal forearm fractures in children has traditionally been closed reduction and pin fixation, although they might heal and remodel without surgery with no functional impairment. No randomized controlled trials have been published comparing the patient-reported functional outcome following non-surgical or surgical treatment of displaced paediatric distal forearm fractures.
    METHODS: A multicentre non-inferiority randomized controlled trial. Children aged 4-10 years with a displaced distal forearm fracture will be offered inclusion, if the on-duty orthopaedic surgeon finds indication for surgical intervention. They will be allocated equally to non-surgical treatment (intervention) or surgical treatment of surgeon\'s choice (comparator). Follow-up will be 4 weeks and 3, 6, and 12 months. The primary outcome is the between-group difference in 12 months QuickDASH score. We will need a sample of 40 patients to show a 15-point difference with 80% power.
    CONCLUSIONS: The results of this trial may change our understanding of the healing potential of paediatric distal forearm fractures. If non-inferiority of non-surgical treatment is shown, the results may contribute to a reduction in future surgeries on children, who in turn can be treated without the risks and psychological burdens associated with surgery.
    BACKGROUND: www.
    RESULTS: gov (ID: NCT05736068). Date of registry: 17 February 2023.
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