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临床试验/NCT03977389
NCT03977389已完成不适用

Total Wrist Denervation: Survival Study and Functional Outcomes

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2018年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
survival over time

研究概览

简要总结

The purpose of the study is to evaluate the long-term effectiveness of total wrist denervation on pain by assessing the surgery survival.

The residual functional wrist's quality and the patients' satisfaction will also be evaluate.

详细描述

The degenerative diseases of the wrist are numerous and include both post-traumatic osteoarthritis lesions and inflammatory diseases. In any case, one of the main reasons for consultation is pain. In case of inefficiency of a well-conducted medical treatment (splints, anti-inflammatories, infiltrations), surgical management remains difficult because of the multitude of treatments that can be offered: partial or total arthrodesis of the wrist, prosthetic arthroplasties, pyrocarbon implants or proximal row carpectomy. But these treatments are heavy and can potentially be sources of complications such as stiffness, loss of strength or progressive wear of the implant.

Total wrist denervation is an alternative since 1966. The original technique follows an anatomical study of the innervation of the upper limb. This technique has been proven to significantly improve pain without major after effects. Several teams demonstrated a decrease in pain associated with conserved strength and mobility, but few studies have studied the long-term results of this technique, especially on the absence of residual pain.

The purpose of this study is to evaluate the long-term effectiveness of denervation on pain by assessing the surgery survival, the residual functional wrist's quality and the patients' satisfaction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patient undergoing total wrist denervation between January 1995 and December 2013 at Brest CHRU, performed by the same senior surgeon

排除标准

  • patient who had another intervention at the same time (confounding factor)
  • refusal expressed by the patient to participate in the study

结局指标

主要结局

survival over time

时间窗: from date of surgery until the date of first documented failure (surgical revision; pain > 3), assessed up to the inclusion date

duration (in years) of absence of surgical revision, and residual pain \< or = 3 on a pain numerical scale (0 to 10, WHO criteria for mild pain)

次要结局

  • patients' satsfaction (2)(at the inclusion date)
  • surgery survival over time(from date of surgery until the date of documented failure (surgical revision), assessed up to the inclusion date)
  • residual functional wrist's quality(at the inclusion date)
  • residual pain(at the inclusion date)
  • patients' satisfaction (1)(at the inclusion date)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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