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临床试验/NCT06631651
NCT06631651已完成不适用

The Effect of Intraoperative Brachioradialis Release on Radiological and Functional Outcomes in Distal Radius Fractures: Long-Term Results

Hüseyin Emre Tepedelenlioğlu2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2019年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
2
主要终点
Operation time

研究概览

简要总结

Distal radius fractures are increasingly common, necessitating surgical intervention in many cases for optimal outcomes. Volar plate fixation has emerged as a preferred surgical method due to its effectiveness in promoting faster healing. However, challenges persist in achieving anatomical reduction, particularly concerning the styloid process, where the brachioradialis muscle insertion complicates the procedure. This study explores the impact of intraoperative brachioradialis release on wrist and elbow functions in distal radius fractures.

详细描述

This two-stage study was conducted in 124 patients who underwent surgery for distal radius fracture between 2011 and 2019. In the first phase, the anatomical alignment of the distal radius was analysed retrospectively. In the second phase, functional assessments of the patients' upper extremities were performed. Patients who underwent open reduction and internal fixation (ARIF) for distal radius end fractures and who agreed to participate in the study were included. Patients who were treated with a method other than ARIF, who had bilateral injuries (valid only for the second phase), who had a fracture in a bone other than the radius, and who had any other neurological or orthopaedic disorder that would affect the assessment were not included in the study.

For the first phase, 124 patients were divided into 2 groups: patients with brachioradialis release (76 patients) and patients without brachioradialis release (38 patients). The release of the brachioradialis muscle was achieved through partial release from its insertion into the styloid process, rather than through Z-plasty. In both groups, the pre- and post-operative radiographs of the operated patients were analysed and the operative times of the operations were recorded. The Dresdner score was calculated by measuring the preoperative and postoperative joint grading, radial tilt angle, palmar tilt angle and ulnar variance on the radiographs. A lower Dresdner score indicated better anatomical alignment.

For the second phase, 124 patients were contacted by telephone. Sixty-one patients who could not be reached or did not meet the inclusion criteria were excluded from the study. The remaining 63 patients were divided into two groups: brachioradialis release and non-brachioradialis release.

In the second stage, hand, wrist and elbow strength, proprioceptive function and disability level of the patients were assessed as functional assessments. The Jebsen Hand Function Test (JEFT) was used to assess hand function.

Wrist flexion-extension, elbow flexion-extension and forearm supination-pronation forces were assessed using an isokinetic dynamometer (Cybex NORM®; Humac, CA, Computer Sports Medicine, Inc., Stoughton, MA).

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 (Participant)

盲法说明

Patients' ID will/did not be revealed

入排标准

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

入选标准

  • Voluntary patients with distal radius fractures requiring operation

排除标准

  • 未提供

研究组 & 干预措施

Classic (Non-brachioradialis Release) Group

Sham Comparator

During distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed

干预措施: Brachioradialis not released (Procedure)

Brachioradialis Release Group

Experimental

During distal radius fracture surgery (open reduction+internal fixation) partial brachioradialis release from the insertion of brachioradialis muscle was performed in order to perform reduction of fracture

干预措施: Brachioradialis release (Procedure)

结局指标

主要结局

Operation time

时间窗: 9 months

To compare the time taken by the surgical methods, the operation times were compared. For this, the start and end times of the operation were analyzed

Anatomical alignment

时间窗: 9 months

Dresdner score was calculated by measuring preoperative and postoperative joint grading, radial inclination angle, palmar inclination angle and ulnar variance on radiography.

Strength Tests

时间窗: 9 months

Hand, wrist, forearm, and elbow strengths were evaluated with iskoniteic dynamometer

Proprioception measurement

时间窗: 9 months

Hand, wrist, forearm, and elbow proprioceptions were evaluated with iskoniteic dynamometer

functional capacity

时间窗: 9 months

Jebsen hand function test was performed to evaluate hand function.

Disability level

时间窗: 9 months

The Turkish version of the Disability Assessment of Arm, Shoulder and Hand Injury Questionnaire (DASH-T) was used to assess the participants' disability during activities of daily living.

pinch and grip forces

时间窗: 9 months

Key pinch, palmar pinch, tip pinch and gross grip strengths were evaluated with a dynamometer.

次要结局

未报告次要终点

研究者

发起方
Hüseyin Emre Tepedelenlioğlu
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Hüseyin Emre Tepedelenlioğlu

M.D., Ph.D.

Ankara Etlik City Hospital

研究点 (2)

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