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临床试验/NCT04962490
NCT04962490招募中不适用

Study of the Repair of Flexor Tendons of the Hand: Epidemiological and Prognostic Factors Associated With Tendon Injuries in Zone II

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Range of motion (ROM)

研究概览

简要总结

Injury to the flexor tendons of the fingers of the hand is a frequent and disabling injury, since it produces tendon retraction and functional limitation. A prompt and adequate diagnosis and treatment is required to minimize the risk of tendon retraction, re-rupture, reoperation rate, and the presence of tendon adhesions that limit the range of motion. On occasions, the limitation of the articular balance of the MCP, PIP and DIP joints generates a loss of strength and difficult in completely closing the fingers to the palm of the hand.

详细描述

To retrospectively evaluate the results obtained with the suture/ reinsertion of the flexor tendons of the hand, in the acute, subacute and chronic phases, treated surgically in our center between the years 2000 and 2021.

To evaluate the clinical and functional results obtained in patients who underwent surgery for a section of the flexor tendons, superficial, profundus or both, preferably in zone II of the hand. The investigators evaluate the epidemiological and prognostic factors associated with the injury, in the different phases and anatomical zones.

The researchers evaluate the functional results:

Pain at rest with movements: Assessed using the visual analogue pain scale (VAS Scale from 0 to 10).

Joint balance / Range of motion of the MCP, PIP, DIP joints. Evaluation by digital goniometer. Evaluation using Buck-Gramcko (1976) and using the Tang (2007) criteria.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with section of the superficial and / or profundus flexor tendons in the hand.
  • Patients with section of the flexor tendon in the thumb
  • Tendon injury in any anatomical area
  • In the acute, subacute or chronic phases of the disease
  • Associated or not with fractures
  • Associated or not with arterial or nerve injuries

排除标准

  • Previous bone disease
  • History of tendon injury to the extensor or flexor tendons
  • Joint stiffness prior to tendon section
  • Rheumatic arthropathy
  • History of operations in the same area.

结局指标

主要结局

Range of motion (ROM)

时间窗: 12 months

Change in the mobility of the MCP, PIP and DIP joints. Evaluation with goniometer (cm)

Grip Strength

时间窗: 12 months

Change of strength with respect to the contralateral hand. Evaluation with Jamar Dinamometer (Kg)

Chronic residual pain

时间窗: 12 months

Evaluation residual pain at rest and with activity with the Visual Analogue Scale (values from 0 to 10; 0 is the better outcome and 10 is the worse outcome).

次要结局

  • Epidemiological variables age, sex, smoker, diabetes, heart disease, other diseases (lung, kidney, etc.).(12 months)
  • Trauma variables(12 months)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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