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临床试验/NCT07344077
NCT07344077招募中不适用

Comparison of Radiographic and Functional Outcomes of Minimal Invasive Distal Metatarsal Osteotomy Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus: A Randomized Controlled Trial

Queen Savang Vadhana Memorial Hospital, Thailand1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Hallux Valgus Angle ( HVA )

研究概览

简要总结

Comparing the radiographic and functional outcomes by using a Minimal invasive procedure to treat Hallux Valgus ; Distal linear Metatarsal Osteotomy -

1 Kirshner wire fixation versus two Kirshner wire fixation

详细描述

This is a randomise controlled trial between two groups patients, which are assigned to two different interventions, undergoing minimal invasive Hallux valgus surgery.

2nd generation of Minimal invasive surgery was selected in hallux valgus surgery due to its availability, cost effectiveness, reduced pain , and the overall simplicity of the operation, providing smaller surgical scars, and less op time , as well as blood loss.

this was done by making a osteotomy cut at the first metatarsal neck and placing one intramedullary Kirshner wire through the first metatarsal joint.

However the stability and the complication of this technique still remains - such as recurrence, K wire loosening, pin tract infection and malunion.

We believe that by adding another intramedullary Kirshner wire to fix the first metatarsal accoss the Metatarsophalangeal joint, the stability of the construct will improve and maintain a reduced hallux valgus angle ,and reduce the rate of complications , ultimately improving pain and functional outcome of the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • age 18-60 year
  • pain along medial surface of first MTP joint
  • radiographic finding : medial deviation of first Metatarsal bone , and lateral deviation of Big toe
  • complete a follow up period of 1 year , filling questionaires and undergone radiographic examination every visit
  • radiographic finding : Hallux valgus angle >20 , Intermetatarsal angle > 10 degrees
  • failed conservative treatment for atleast 8 months , with persistent pain along medial eminence and having difficulty walking, bearing weight

排除标准

  • previous injury/fracture at big toe
  • deviation/ subluxation of 1st MTP joint from traumatic event
  • arthritic change of metatarsal bone, phalangeal bone of big toe
  • previous/active infection , open wound along first metatarsal and big toe
  • patient denied enrolling in study

研究组 & 干预措施

fixation with two kirshner wire in DLMO Surgery

Experimental

adding another kirshner wire through the osteotomized first metatarsal bone

干预措施: 2 Kirshner wire fixation (Procedure)

fixation with one kirshner wire in DLMO surgery

No Intervention

using a standard technique of one kirshner wire fixation at first metatarsal bone

结局指标

主要结局

Hallux Valgus Angle ( HVA )

时间窗: baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month

degree of long axis of first Metatarsal to first proximal phalanx big toe

次要结局

未报告次要终点

研究者

发起方
Queen Savang Vadhana Memorial Hospital, Thailand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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