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临床试验/NCT01467752
NCT01467752已完成1 期

Phase 1 Study for Reconstruction of Metacarpophalangeal Joint Using a Vascularized Cartilage and Bone Graft From the Third Metacarpal

The Second Hospital of Qinhuangdao1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Range of motion; Arm, Shoulder and Hand questionnaire

研究概览

简要总结

Traumatic cartilage loss of the joint is central to the development of joint failure in arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal joint defects.

详细描述

The metacarpophalangeal joint is vital for hand function. Cartilage loss of the joint is central to the development of joint failure in arthritis. Although various treatments have been proposed, the management remains a challenging problem.Previous anatomical studies have shown that, at the base of the metacarpal, there were nutrient arteries inserting into the dorsum of the metacarpal. The nutrient arteries arise from the distal and middle dorsal carpal arches that run distally to the first to fourth dorsal metacarpal arteries (DMAs. These studies prompt us to use a reverse vascularized cartilage and bone graft based on the DMA. The metacarpal consists of a widened proximal base. The joint surface to the capitate is convex anteriorly and dorsally concave, where it extends to the styloid process on the dorsolateral aspect of the metacarpal base. The unique contour stimulates our imagination and creativity to use a portion of the joint surface for reconstruction of metacarpophalangeal joint defects. The purpose of this study is to report the novel technique and to evaluate the effectiveness of the treatment.

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
Single (Participant)

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

  • a cartilage defect at either proximal or distal MCP joint;
  • either an acute or old injury;
  • loss of 1/4 of joint entire surface that seen on plain radiographs, CT scan, and intraoperative finding;
  • and with or without MCP joint subluxation.

排除标准

  • large defects involved double joint surfaces;
  • the size of the defect involving less than 1/4 of the joint surface;
  • associate with infection or other diseases that restrict to use the technique.

结局指标

主要结局

Range of motion; Arm, Shoulder and Hand questionnaire

时间窗: 4 years

The active motions of the hand were measured by a goniometer. The patients rated their MCP joint pain, the donor joint pain, and scar pain using a line by a visual analogue scale (VAS). We used the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire to assess the hand function.

次要结局

  • Pain(4 years)

研究者

发起方
The Second Hospital of Qinhuangdao
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Zhang

Director

The Second Hospital of Qinhuangdao

研究点 (1)

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