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临床试验/NCT02679066
NCT02679066终止不适用

Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
200
试验地点
1
主要终点
Number of Participants With Maintenance of Reduction

研究概览

简要总结

There is no consensus regarding the need to immobilize the elbow in immediate immobilization of closed distal radius fractures post-reduction. Decreased functionality of the upper extremity is a notable morbidity associated with below-elbow splinting of distal radius fractures post-reduction. Few studies have provided evidence comparing sugar tong splinting versus short-arm casting as methods of immediate post-reduction immobilization. The study will randomize patients with close distal radius fractures to short forearm casting versus sugar tong splinting with close follow up including radiographic and clinical evaluation.

This will provide guidance regarding the need for short forearm cast immobilization versus sugar tong splinting in early maintenance of reduction of closed distal radius fractures, as well as functional effects of sugar tong splinting versus short forearm casting.

详细描述

Objectives (include all primary and secondary objectives)

To determine the success of sugar tong splinting versus short arm casting for maintenance of reduction of closed distal radius fractures and to compare the functional outcomes in patients treated with sugar tong splinting versus short forearm casting as guidance for immediate post-reduction immobilization of these fractures.

Primary objectives:

Background (briefly describe pre-clinical and clinical data, current experience with procedures, drug or device, and any other relevant information to justify the research)

  • Koval et al. randomized patients to long-arm versus short-arm splinting of post-reduction closed distal radius fractures and reported comparable maintenance of reduction with better functional scores in patients immobilized in a short-arm splint and thus recommended this method for immediate post-reduction immobilization of closed distal radius fractures (Bong et al. 2006).
  • Grafstein et al. randomized 101 adult patients with closed distal radius fractures to sugar tong splinting versus above-elbow circumferential casting versus above-elbow volar-dorsal splinting for immediate post-reduction immobilization and followed patients closely for 3 to 4 weeks. They reported no significant difference in loss of reduction, pain scores, range of motion, or Activities of Daily Living (ADLs) between the three methods of immobilization and thus recommended treatment with any method with which the treating physician is most comfortable (Grafstein et al., 2010).
  • Millet and Rushton randomized 99 women with closed distal radius fractures to below elbow plaster casts versus initial plaster casting followed by flexible casting to allow early joint range of motion and reported increased comfort, grip scores and joint mobility in early treatment period without negative effects of early motion and thus concluded that early mobilization can be a beneficial treatment option (Millet and Rushton, 1995).
  • Pool prospectively studied range of motion and radiographic parameters over a two year period in over 200 patients with Colles' fractures treated with five different combinations of above- and below-elbow immobilization and concluded that while all patients went onto union and adequate function, those immobilized in above-elbow plaster lost some degree of supination. He found no benefit to above-elbow immobilization and recommended only below-elbow post-reduction immobilization (Pool, 1973).
  • Sarmiento reviewed a case series of 44 patients with intra-articular distal radius fractures treated initially with an above-elbow cast initially and transitioned early to a brace allowing elbow and wrist range of motion while restricting pronation-supination and concluded that although fracture collapse did occur, functional results were good and the early mobilization reduced the stiffness and incapacitation associated with treatment of distal radius fractures (Sarmiento et al.)

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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult > 18 years of age
  • Closed fracture
  • Isolated injury
  • No prior injury to ipsilateral forearm
  • Less than or equal to two attempts at reduction

排除标准

  • Ipsilateral upper extremity injury
  • Open injury or neurovascular compromise
  • Greater than two attempts at reduction
  • Presentation greater than 24 hours after injury

结局指标

主要结局

Number of Participants With Maintenance of Reduction

时间窗: one month

Radiologic parameters to include radial height, radial inclination and volar tilt will be measured from post-immobilization radiographs at presentation, one week, two weeks and four weeks. Maintenance of reduction will be defined as: loss of reduction of \< 2 mm radial height, \< 5 degrees of radial inclination or \< 10 degrees of volar tilt and/or \< 2 mm intra-articular step off, in follow up radiographs as compared to immediate post-reduction radiographs.

次要结局

  • Disabilities of the Arm, Shoulder and Hand (DASH) Score - Upper Extremity Function(Two weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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