Finger ReplantationNCT07029763
Assessment of Functional Outcomes Following Successful Finger Replantation
An observational study of Finger Replantation, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Finger Replantation
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A prospective study will be conducted including all patients who have undergone successful finger replantation following traumatic amputations at the Plastic and Reconstructive Surgery Department, Sohag University Hospital between April 2025 and October 2026 with a follow up period at least 6 months.
Who may be able to join
- Patients who suffered traumatic digit injuries leading to total amputation as defined by Biemer (Biemer, 1980).
- Multiple digit replantation.
Who cannot join
- Multiple level amputations.
- Bad general condition.
- Mutilating hand injuries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Ahmed Talaat, Ass lecturer, +2001013610088, drahmed202022@gmail.com
About this study
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.
- Conditions
- Finger Replantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (ROM)
A goniometer will be used to determine the range of motion (ROM) of the metacarpophalangeal and interphalangeal joints of the replanted digits.
Measured: At least 6 months after replantation
Finger flexion and extension of replanted digits
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.
Measured: At least 6 months after replantation
Grip and pinch strengths
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°.
Measured: At least 6 months after replantation
Recovery of sensibility
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.
Measured: At least 6 months after replantation
Pain intensity
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.
Measured: At least 6 months after replantation
DASH score
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.
Measured: At least 6 months after replantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finger ReplantationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Talaat Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029763
- Sponsor's protocol ID
- Soh-Med-25-5_2MD
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Outcomes Following Successful Finger Replantation
- ClinicalTrials.gov ID
- NCT07029763
- Acronym / sponsor ID
- Soh-Med-25-5_2MD
- Conditions
- Finger Replantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A prospective study will be conducted including all patients who have undergone successful finger replantation following traumatic amputations at the Plastic and Reconstructive Surgery Department, Sohag University Hospital between April 2025 and October 2026 with a follow up period at least 6 months.
Key inclusion criteria (2 listed)
- Patients who suffered traumatic digit injuries leading to total amputation as defined by Biemer (Biemer, 1980).
- Multiple digit replantation.
Key exclusion criteria (3 listed)
- Multiple level amputations.
- Bad general condition.
- Mutilating hand injuries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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°.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Finger Replantation, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (ROM) (time frame: At least 6 months after replantation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.