Amputation StumpNCT07102654
Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain
An observational study of Amputation Stump and Amputation Neuroma, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial summary
The goal of this prospective observational study is to assess the post-operative pain in adults with digital amputation following two different surgical interventions: microanastomosis of digital nerves or traction neurectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Stump, Amputation Neuroma, Amputation, Traumatic/Surgery
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals presenting at the Centre Hospitalier de l'Université de Montréal for a digital amputation
Who may be able to join
- Age ≥ 18 years
- Patients who have undergone a traumatic digital amputation
- Patients treated with one of the two following techniques: microanastomosis of digital nerves or traction neurectomy
- Postoperative follow-up of at least 6 months
Who cannot join
- Patients treated with a surgical intervention other than microanastomosis of digital nerves or traction neurectomy for digital amputation
- Non-traumatic amputations (e.g., cancer or infection)
- Follow-up of less than 6 months
- Patients with pre-existing peripheral neuropathy
About this study
Official title: Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain: A Prospective Study
The goal of this prospective observational study is to assess the post-operative pain in adults with digital amputation following two different surgical interventions: microanastomosis of digital nerves or traction neurectomy. The main questions it aims to answer are:
- Which surgical intervention results in less post-operative pain?
- Which surgical intervention leads to fewer symptoms after six months?
- Which surgical intervention is associated with fewest post-operative complications? Participants will complete a Visual Analog Scale (VAS) to assess the pain and the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) to evaluate the disabilities.
The researchers will assess post-operative complications during follow-up appointments.
- Keywords
- microanastomosis, traction neurectomy, digital amputation, digital nerve
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Measured by Visual Analog Scale in Adult Patients Following Digital Amputation
The primary objective of this study is to compare the level of postoperative pain associated with two surgical techniques: microanastomosis of digital nerves and traction neurectomy. Pain will be measured using the visual analog scale at one week, four weeks, and six months following the procedure. The visual analog scale ranges from 0 ( no pain) to 10 (worst imaginable pain).
Measured: 1 week, 4 weeks and 6 months
Postoperative Symptoms Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire in Adult Patients Following Digital Amputation
The secondary objective of this study is to compare the level of postoperative symptoms associated with two surgical techniques: microanastomosis of digital nerves and traction neurectomy. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will assess disability and hand-related symptoms at 6 months. The score ranges from 0 (no disability) to 100 (most severe disability)
Measured: 6 months
Secondary outcomes (1)
Complication Rate of Microanastomosis of Digital Nerves and Traction Neurectomy in Adult Patients Following Digital Amputation
The tertiary objective of this study is to determine the incidence of postoperative complications for both microanastomosis of digital nerves and traction neurectomy.
Measured: 1 week, 4 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation StumpStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102654
- Sponsor's protocol ID
- 2026-13097
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain: A Prospective Study
- ClinicalTrials.gov ID
- NCT07102654
- Acronym / sponsor ID
- 2026-13097
- Keywords
- microanastomosis, traction neurectomy, digital amputation, digital nerve
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Aug 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 goal of this prospective observational study is to assess the post-operative pain in adults with digital amputation following two different surgical interventions: microanastomosis of digital nerves or traction neurectomy. The main questions it aims to answer are:
- Which surgical intervention results in less post-operative pain?
- Which surgical intervention leads to fewer symptoms after six months?
- Which surgical intervention is associated with fewest post-operative complications? Participants will complete a Visual Analog Scale (VAS) to assess the pain and the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) to evaluate the disabilities.
The researchers will assess post-operative complications during follow-up appointments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting at the Centre Hospitalier de l'Université de Montréal for a digital amputation
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients who have undergone a traumatic digital amputation
- Patients treated with one of the two following techniques: microanastomosis of digital nerves or traction neurectomy
- Postoperative follow-up of at least 6 months
Key exclusion criteria (4 listed)
- Patients treated with a surgical intervention other than microanastomosis of digital nerves or traction neurectomy for digital amputation
- Non-traumatic amputations (e.g., cancer or infection)
- Follow-up of less than 6 months
- Patients with pre-existing peripheral neuropathy
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
Postoperative Pain Measured by Visual Analog Scale in Adult Patients Following Digital Amputation
Time frame: 1 week, 4 weeks and 6 months
The primary objective of this study is to compare the level of postoperative pain associated with two surgical techniques: microanastomosis of digital nerves and traction neurectomy. Pain will be measured using the visual analog scale at one week, four weeks, and six months following the procedure. The visual analog scale ranges from 0 ( no pain) to 10 (worst imaginable pain).
Postoperative Symptoms Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire in Adult Patients Following Digital Amputation
Time frame: 6 months
The secondary objective of this study is to compare the level of postoperative symptoms associated with two surgical techniques: microanastomosis of digital nerves and traction neurectomy. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will assess disability and hand-related symptoms at 6 months. The score ranges from 0 (no disability) to 100 (most severe disability)
1 secondary outcome
Complication Rate of Microanastomosis of Digital Nerves and Traction Neurectomy in Adult Patients Following Digital Amputation
Time frame: 1 week, 4 weeks, 6 months
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 15 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation Stump and Amputation Neuroma, run by Centre hospitalier de l'Université de Montréal (CHUM).
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Measured by Visual Analog Scale in Adult Patients Following Digital Amputation (time frame: 1 week, 4 weeks and 6 months). The study lists 2 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 15 Sep 2025.