跳至主要内容
临床试验/NCT07029763
NCT07029763招募中不适用

Assessment of Functional Outcomes Following Successful Finger Replantation

Sohag University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Range of motion (ROM)

研究概览

简要总结

The functional outcomes following finger replantation are assessed using a combination of objective measures such as grip strength, range of motion, and sensory testing and subjective evaluations, such as patient-reported outcomes regarding pain, satisfaction, and ability to perform daily activities. Various scoring systems have been developed to standardize the assessment of these outcomes, but differences in methodology, patient demographics, and injury types often make direct comparisons difficult. Despite these challenges, it remains clear that the benefits of replantation extend beyond simply salvaging the digit; the restoration of function is a key determinant in the success of the procedure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who suffered traumatic digit injuries leading to total amputation as defined by Biemer (Biemer, 1980).
  • •Multiple digit replantation.

排除标准

  • •Multiple level amputations.
  • •Bad general condition.
  • •Mutilating hand injuries.

结局指标

主要结局

Range of motion (ROM)

时间窗: At least 6 months after replantation

A goniometer will be used to determine the range of motion (ROM) of the metacarpophalangeal and interphalangeal joints of the replanted digits.

Finger flexion and extension of replanted digits

时间窗: At least 6 months after replantation

The fingertip-to-palm distance (FPD) and fingertip-to-table distance (FTD) will be used to assess deficits in finger flexion and extension of replanted digits.

Grip and pinch strengths

时间窗: At least 6 months after replantation

Jamar hand dynamometer will be used to determine the grip and pinch strengths. Grip and pinch measurements will be taken in the standardized sitting position with the shoulder of the patient kept in the neutral position and the elbow flexed to 90°.

Recovery of sensibility

时间窗: At least 6 months after replantation

The static two-point discrimination (2-PD) and Semmes-Weinstein monofilament test (SWM test) will be used to evaluate the sensory recovery of the radial and ulnar digital nerves of all injured fingers. Normal sensibility is defined as the sensibility assessed at the corresponding contralateral uninjured digits. The two-point discriminator consists of a plate with several pins with adjustable separations ranging from 1 to 15 mm in steps of 1 mm. The patients will be asked to close their eyes during the examination. One or two pins will be applied perpendicularly to the radial and ulnar finger pulp and held for at least 3 seconds. Three repeated responses will be necessary for the final score.

Pain intensity

时间窗: At least 6 months after replantation

Only patients with a single-digit injury will be included for these evaluations. This is because patients with multiple-digit injuries will be expected to have a higher pain level than patients with a single-digit injury and their inclusion would, therefore, bias the results. On a scale from 0 to 10, the pain intensity at rest, under strain, and in cold temperatures will be reported, with a higher number indicating increased pain.

DASH score

时间窗: At least 6 months after replantation

The disability of the arm, shoulder, and hand (DASH) questionnaire will be used for subjective evaluations. Only patients with a single-digit injury will be included for these evaluations. This is because patients with multiple-digit injuries will be expected to have a higher DASH score than patients with a single-digit injury and their inclusion would, therefore, bias the results. The DASH questionnaire contains 30 questions on daily living activities for assessing the patient's disabilities in the upper extremities. Each question is scored on a five-point scale from 1 to 5. The score calculation ranged from 0 to 100, while a higher DASH score indicated increased disability. At least 27 of the 30 items will be needed to obtain a valid score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Talaat Ahmed

Egypt, Sohag, Elmaragha

Sohag University

研究点 (1)

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