跳至主要内容
临床试验/NCT05525988
NCT05525988进行中(未招募)不适用

Proximal Pole Scaphoid Reconstruction Using Proximal Hamate: Case-Series on A Novel Technique

Ain Shams University2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
6
试验地点
2
主要终点
Union Rate

研究概览

简要总结

Recently, A novel surgical technique was illustrated by Elhassan BT et al. in 2016 utilizing the Hemi-hamate autograft for the reconstruction of scaphoid bone proximal pole non-union with avascular necrosis.

The technique showed promising results but is still limited to case reports and anatomical studies

In this study, we aim to:

  1. Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique.
  2. Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function.
  3. Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.

详细描述

Almost 70 percent of all carpal bone fractures occur in the scaphoid bone, with an overall incidence of 12 per 100,000 of the general population. About 20 percent of scaphoid bone fractures are in the proximal third of the scaphoid, where the rates of ischemia were reported to be as high as 100 percent.

The risk of avascular necrosis (AVN) and/or non-union that in due course end in arthrosis with the fractures involving the proximal pole of the scaphoid is high and represents a challenging surgical problem, and even more challenging when the proximal pole is fragmented.

Several techniques were described for the surgical management of non-union of the proximal pole of scaphoid, including non-vascularised and vascularized bone grafts, each has characteristic pros and cons. Drawbacks with all of these techniques included donor-site morbidity and/or the requirement of microvascular skill in the case of a vascularized bone graft.

The Hemi-Hamate graft is the closest anatomically and histologically to the scaphoid compared to the rib costochondral and the medial femoral condyle grafts. The proximal part of the hamate has an analogous sizing and morphology to the proximal pole of the scaphoid bone. Both have a similar depth (palmar-dorsal breadth), width (radial-ulnar breadth), and sagittal radius of curvature.

Osteotomized proximal hamate with a maximum graft length at a level proximal to the hamulus distally did not adversely affect the lunate-capitate or the scaphoid-lunate kinematics during the wrist joint flexion-extension and the radial-ulnar deviation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Multifragmentary fracture of the proximal pole of scaphoid where fragments cannot be fixated.
  • Participants with small and poor-quality proximal pole scaphoid bone fracture after the failure of a previous surgical fixation or bone grafting.

排除标准

  • Proximal hamate arthrosis.
  • Preexisting midcarpal instability.
  • Arthritis at the radioscaphoid joint.
  • Large hamate bone (Hamate radial-ulnar breadth greater than 1 cm in a participant with scaphoid bone radial-ulnar breadth less than 1 cm and palmar-dorsal breadth of less than 1.6 cm).

结局指标

主要结局

Union Rate

时间窗: 6 months postoperatively

Reaching 50 percent graft union at the fracture site by Computed Tomography (CT) utilizing 1 mm thin cuts along the scaphoid long axis. \[Done at the 6-week post-operative clinic visit to assess for the bone union and will be performed in monthly intervals till the bony union.\]

次要结局

  • Time to Union(A 6 months postoperatively)
  • Complications(Intraoperatively to 1-year postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Proximal Pole Scaphoid Reconstruction Using Proximal... | 临床试验