跳至主要内容
临床试验/CTRI/2024/07/070405
CTRI/2024/07/070405尚未招募不适用

Functional outcome of modified percutaneous needle aponeurotomy for Dupuytren’s disease

Dr Navaneeth P K1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
23
试验地点
1
主要终点
Quick DASH Score, URAM Scale and range of motion of the affected fingers

研究概览

简要总结

This prospective observational study aims to assess the functional outcomes of patients with Dupuytren’s contracture treated with modified percutaneous needle aponeurotomy technique. Patients were evaluated according to their demographic characteristics, presence of comorbidities, family history, history of drug use. The primary outcome measures will be postoperative Quick-Disability of Arm Shoulder and Hand Questionnaire (Quick-DASH) and URAM scale at 6 months follow up and Secondary outcomes will include a safety assessment, as judged by incidence rate and severity of adverse effects (eg, pain or limited activity) and recurrent rate.

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研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Symptomatic MCP joint contracture with a palpable cord (not beyond stage 2 Tubiana), 2)PIP joint contracture less than 15 degrees, 3)Compliant patient.

排除标准

  • Severe PIP joint contracture, 2)Skin shortage, scarring , tight skin, 3)Aggressive systemic disease, 4)Non-compliant patient.

结局指标

主要结局

Quick DASH Score, URAM Scale and range of motion of the affected fingers

时间窗: 6 months

次要结局

  • Secondary outcomes will include a safety assessment, as judged by incidence rate and severity of adverse effects (eg, pain or limited activity)(1 year)
  • Recurrent rate(1 year)

研究者

发起方
Dr Navaneeth P K
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Navaneeth P K

KMC Manipal, MAHE Manipal

研究点 (1)

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