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临床试验/NCT06920823
NCT06920823已完成不适用

Comparison of Antegrade and Retrograde Fixation With Intramedullary Headless Canulated Screws in Patients With Metacarpal Fractures

Pamukkale University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年10月4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
入组人数
22
试验地点
1
主要终点
Radiographic Examination (anteroposterior and oblique diameter)

研究概览

简要总结

Purpose: Intramedullary fixation has proven to be an efficacious intervention for metacarpal fractures. Advantages involve stable fixation facilitating early surgical rehabilitation and higher fracture union rates, without increased morbidity. We aimed to compare the results of fixation of metacarpal fractures with headless cannulated screws towards antegrade or retrograde on pain, function and quality of life in patients with metacarpal fractures.

Methods: Patients admitted to Pamukkale University Orthopedics and Traumatology Department, due to metacarpal fracture were prospectively included in the study and randomly grouped. A total of 22 patients and 26 metacarpal fractures were assessed. Group I patients were operated with antegrade(proximal entry) , and group II with retrograde (distal entry) , using intramedullary headless cannulated screws. Appropriate screw selection was made by measuring the metacarpal isthmus diameter of the patient's x-ray results (AP and oblique direction). We used headless cannulated screws with diameters between 3.5mm and 5mm in the fractures.

详细描述

This was a prospective randomised comparative single-blinded study comparing the effects of intramedullary fixation direction and entry site in patients with metacarpal fractures.

The participants were first evaluated at post-operative 6th week and the last evaluation was performed at post-operative 12th week The evaluations included radiographic union, grip strength measurement (with Jamar hydraulic hand dynamometer), range of motion measurement (compared to the opposite hand), and Michigan Hand Outcome Questionnaire (MHQ) questionnaire. All assessments were performed by the same investigator. The researcher who performed the evaluations did not know which group the participants were in.

In the antegrade headless cannulated screw fixation technique, a small incision was made on the extensor aspect of the fractured metacarpal at the level of the carpometacarpal (CMC) joint and the extensor tendon was excised. After fracture reduction, k-wire was inserted intramedullarly. After appropriate drilling, 1 headless cannulated screw was applied distally.(figure 1) In the fixation technique with retrograde headless cannulated screw, a small incision was made on the extensor side of the fractured metacarpal at the level of the MCP joint, and the extensor tendon split was passed. After fracture reduction, k-wire was inserted intramedullarly. After appropriate drilling, headless cannulated screw was applied proximally.

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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Operated for metacarpal fracture,
  • •Speak and understand Turkish,
  • •Understand the verbal and written information given.
  • •Regular follow-up visits

排除标准

  • •Open epiphysis
  • •Pathological fractures
  • •Fractures requiring bone grafting

研究组 & 干预措施

Group 2

Active Comparator

retrograde (distal entry) fixation

干预措施: retrograde (distal entry) fixation (Procedure)

Group 1

Active Comparator

antegrade (proximal entry) fixation

干预措施: antegrade (proximal entry) fixation (Procedure)

结局指标

主要结局

Radiographic Examination (anteroposterior and oblique diameter)

时间窗: postop 6th week

Primary bone healing was accepted as union when callus tissue developed in at least 3 cortices on AP and oblique radiographs taken with a radiography device or on the 6th week control radiograph. Radiological measurements were performed by a single observer.

次要结局

  • Range of motion(postop 6th and 12th week)
  • Grip strength(postop 12th week)
  • Hand functionality (Michigan Hand Outcomes Questionnaire)(postop 12th week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

UMUT ERASLAN

assistant professor

Pamukkale University

研究点 (1)

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