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临床试验/NCT05358015
NCT05358015尚未招募不适用

Vascularised Bone Grafts for Treatment of Scaphoid Nonunion: a Case Series Study

Assiut University0 个研究点目标入组 25 人开始时间: 2022年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
主要终点
Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29

研究概览

简要总结

To assess the effect of vascularized bone grafting on the functional, clinical and radiological outcomes of the scaphoid nonunion

详细描述

The scaphoid is the most commonly fractured carpal bone accounting for 60% of fractures. A number of case series have identified a 10%-15% nonunion rate. Scaphoid nonunion refers to a spectrum of failed healing, each of which requires a tailored approach.

Subsequent to non-union, degenerative changes with the formation of cysts, bony resorption with loss of bone stock and the development of apex dorsal angulation or the humpback deformity may occur leading to scaphoid non-union advanced collapse (SNAC) of the wrist and the formation of a proximal pole which extends with the lunate.

This has serious functional implications for the patient in terms of wrist range of movement, grip strength and general activities of daily living . The management of nonunion has remained controversial since the last century.

Bone grafting has been performed since the late 1920s with positive results. The importance of vascularity was enforced by finding that in the presence of avascular necrosis ( AVN ), conventional non vascularized bone grafts ( NVBGs) could only achieve a 47% union rate . However, in the absence of AVN, these NVBGs could achieve union rates of 94% .

There was growing consensus that new techniques were required to address the shortfall, and accordingly, vascularized bone grafting (VBG) techniques stemmed from this. It was widely believed that providing adequate blood flow would help treat cases of non-union . Several studies demonstrate that VBGs accelerated bone healing by preserving osteocytes and preventing the slower creeping substitution and were able to increase blood flow and superior mechanical properties in VBGs as opposed to NVBGs . VBGs could be further classified into pedicled or free VBGs. Pedicled VBGs involve isolating a segment of bone local to the defect and maintaining the blood supply to this segment of donor bone which is then fixed into the recipient site. This requires a good stock of donor bone in close proximity to the defect. Free VBGs involve detaching a segment of bone with its vascular bundle from a donor site and anastomosing this to recipient vessels with the fixation of the donor bone to recipient bone.This study hypothesis that VBGs should be used in all cases of humpback deformity , proximal pole fracture , AVN and cystic degeneration from the start.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All Patients will be included if they met the following criteria:
  • Age: all patient more than 18 years up to 55 years
  • Fracture: nonunion and a vascular necrosis proved by MRI (Herbert stage I or II) , humpback deformity, Proximal pole fracture, cystic degeneration, failed previous surgery (K wire, Herbert, plate distal radius)
  • Pain: persistent disabling pain and tenderness at wrist joint due to scaphoid nonunion.
  • patient: both sex will included, both handiness, good bone quality.

排除标准

  • Commuted Other carpus fractures
  • Nonunion less than 3 months
  • Radio-carpal Arthritis or instability

结局指标

主要结局

Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29

时间窗: 2 years

The final end results will be assessed according to DASH score , a DASH score ranging from 0 to 29 was thought by most respondents to be the point where patients/clients were 'no longer considering their upper-limb disorder a problem .

Mayo wrist score of 60 - 100 will be satisfactory

时间窗: 2 years

The final end results will be assessed according to modified Mayo wrist score of 60 - 100 will be satisfactory . Secondary (subsidiary):

次要结局

  • Carpal Alignment Before and After VBG(2 years)
  • Scapholunate angle(2 years)
  • Scaphoid Height-to-length ratio(2 years)
  • Lateral interscaphoid angle(2 years)
  • Radio-lunate angle(2 years)

研究者

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

Mohamed Mostafa abdelhady Ismail

Doctor

Assiut University

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