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临床试验/NCT05159310
NCT05159310Unknown不适用

A Randomized Controlled Trial Comparing Clinical Outcomes of Casting Versus Splinting in Distal Radius Fractures in Patients 60 Years and Above

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Splinting results in Quick Disabilities of Arm, Shoulder, Hand (QuickDASH) scores that are not poorer as compared to casting

研究概览

简要总结

This study will evaluate and compare the efficacy of 2 commonly-used methods of fracture immobilisation: (1) Fiberglass cast, and (2) Thermoplastic splint. Both these devices are externally applied and provide pain relief while immobilising the fracture in an acceptable position. Casts and splints are both established devices in routine clinical use.

详细描述

Casts and splints are both established methods of treating DRF. Casts have been traditionally the gold standard for non-operative care of fractures, but there are distinct disadvantages such as skin rash and pruritus, malodour, skin maceration and loosening as the initial swelling subsides. Casts require specialized tools for removal and they have to be reapplied by specialized staff if the casts become loose or wet. Splints have the advantage of being removable and therefore facilitate hygiene and provide a better fit because of the adjustable straps. Splints are theoretically less rigid and patient non-compliance because of the ease of removal may result in a greater likelihood of fracture displacement. However, it is known that fractures displace even in casts and the efficacy of casts at maintaining reduction over splints has not been established. Moreover, it has been clearly shown that the elderly patients have good functional outcomes that do not correlate with the position in which the fracture heals i.e. they tolerated a large degree of fracture malunion (Arora; Egol).

The primary goal of this study is to show that there is no difference in the final functional outcome between distal radius fractures treated non-operatively with splints and casts. The secondary goals are to demonstrate: (1) splinting results in greater patient comfort and acceptance; (2) there is no significant difference in final radiographic outcomes between DRF treated with casts and splints; and (3) there is no difference in clinical outcome at the 6-month and 12-month follow-up points.

This study is clinically important for several reasons. First, patients may be encouraged to use splints instead of casts if there is no difference in functional outcome and the former provide better comfort. Second, patients may not be required to present for long (>6-month) follow-ups if it can be shown that the clinical improvement plateaus at 6 months after injury. This is consistent with our aim to improve patients' overall quality of life after musculoskeletal injuries and forms a core component of functional ageing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Closed DRF in patients > 60 years
  • Presenting to HRMC within 10 days of injury
  • Isolated injury
  • With or without M&R performed in EMD
  • Declined surgical fixation after appropriate discussion

排除标准

  • Wounds - skin tears, bad abrasions, open fracture
  • Ulnar fracture > styloid
  • Other MSK / non-MSK injuries
  • Bilateral fractures
  • Prior wrist fractures / wrist surgery
  • Other upper limb conditions affecting function (e.g. CVA)
  • Cognitive impairment
  • Allergy to plaster or fiberglass

结局指标

主要结局

Splinting results in Quick Disabilities of Arm, Shoulder, Hand (QuickDASH) scores that are not poorer as compared to casting

时间窗: 12 months

The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability. Splinting in patients ≥60 years with distal radius fracture (DRF) results in 12-month QuickDASH scores that are significantly inferior compared to scores in patients treated in cast. The alternate hypothesis is that splinting results in 12-month QuickDASH scores that are not significantly inferior compared to casting in this group of patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Cast Vs Splint in Distal Radius Fractures | 临床试验