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NCT Number: NCT07029763

Assessment of Functional Outcomes Following Successful Finger Replantation

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.

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Key information

Conditions

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Range of motion (ROM)

    Time frame: 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.

  2. Finger flexion and extension of replanted digits

    Time frame: 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.

  3. Grip and pinch strengths

    Time frame: 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°.

  4. Recovery of sensibility

    Time frame: 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.

  5. Pain intensity

    Time frame: 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.

  6. DASH score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.