Peripheral Nerve Injury Upper LimbNCT04788030
Reconstruction of Digital Nerve Lesions With Muscle-in-Vein Conduits
An observational study of Peripheral Nerve Injury Upper Limb, run by BG Trauma Center Tuebingen.
Trial summary
Muscle-in-vein conduits (MVCs) provide an alternative for bridging digital nerve defects when tension-free suture is not possible. Low donor site morbidity and absence of additional costs are favorable advantages compared to autografts or conduits. Read more about this study
- Who is it for?
- Ages 6 to 72 years
- Conditions the study is for
- Peripheral Nerve Injury Upper Limb
- What is being tested?
- Nerve reconstruction
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 72 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The mean age of all patients was 38.0 years (SD 18.4, range 6-72). All patients aged younger than 18 years were males whereas patients older than 60 years tend to be females.
Who may be able to join
- Patients with reconstruction of digital nerves with muscle-in-vein conduits
Who cannot join
- Subtotal or total amputations
- pre-existing neurological disorders (e.g. polyneuropathy)
- symptoms of nerve entrapment
About this study
Official title: Outcome After Reconstruction of 43 Digital Nerve Lesions With Muscle-in-Vein Conduits
Muscle-in-vein conduits (MVCs) provide an alternative for bridging digital nerve defects when tension-free suture is not possible. Low donor site morbidity and absence of additional costs are favorable advantages compared to autografts or conduits. 37 patients with 43 defects of proper palmar digital nerves were retrospectively enrolled. Primary repair by MVCs was performed in 22 cases while 21 underwent secondary reconstruction. Recovery of sensibility was assessed by static and moving two-point discrimination (2PDs, 2PDm) and Semmes-Weinstein monofilaments (SWM). Results were compared with contralateral side serving as intraindividual control. Outcome data were stratified according to international guidelines and evaluated for differences in terms of age, gap length, time of reconstruction and concomitant injuries.
- Conditions
- Peripheral Nerve Injury Upper Limb
- Being tested
- Nerve reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve reconstructionOther
Nerve bridging with muscle-in-vein conduits
| Study group | Role | What they receive |
|---|---|---|
| Digital nerve reconstruction with muscle-in-vein conduits | Not described Receives: Other: Nerve reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-point discrimination
Measured: Six months after reconstruction or later
Semmes-Weinstein-Monofilament test
Measured: Six months after reconstruction or later
Secondary outcomes (4)
Age
Measured: Baseline
Gap length
Measured: Baseline
Time of reconstruction
Measured: Baseline
Concomitant injuries
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Jan 2008
- Primary completion31 Dec 2017
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Injury Upper LimbStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- BG Trauma Center Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Theodora Wahler, BG Trauma Center Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788030
- Sponsor's protocol ID
- 650/2018BO2-1
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Reconstruction of 43 Digital Nerve Lesions With Muscle-in-Vein Conduits
- ClinicalTrials.gov ID
- NCT04788030
- Acronym / sponsor ID
- 650/2018BO2-1
- Conditions
- Peripheral Nerve Injury Upper Limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BG Trauma Center TuebingenUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Mar 2021 (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.
Muscle-in-vein conduits (MVCs) provide an alternative for bridging digital nerve defects when tension-free suture is not possible. Low donor site morbidity and absence of additional costs are favorable advantages compared to autografts or conduits. 37 patients with 43 defects of proper palmar digital nerves were retrospectively enrolled. Primary repair by MVCs was performed in 22 cases while 21 underwent secondary reconstruction. Recovery of sensibility was assessed by static and moving two-point discrimination (2PDs, 2PDm) and Semmes-Weinstein monofilaments (SWM). Results were compared with contralateral side serving as intraindividual control. Outcome data were stratified according to international guidelines and evaluated for differences in terms of age, gap length, time of reconstruction and concomitant injuries.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital nerve reconstruction with muscle-in-vein conduits | – | Other: Nerve reconstruction |
Who may qualify
- Ages
- 6 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The mean age of all patients was 38.0 years (SD 18.4, range 6-72). All patients aged younger than 18 years were males whereas patients older than 60 years tend to be females.
Key inclusion criteria (1 listed)
- Patients with reconstruction of digital nerves with muscle-in-vein conduits
Key exclusion criteria (3 listed)
- Subtotal or total amputations
- pre-existing neurological disorders (e.g. polyneuropathy)
- symptoms of nerve entrapment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve reconstructionNerve bridging with muscle-in-vein conduits | Other | Digital nerve reconstruction with muscle-in-vein conduits |
Primary outcome
Two-point discrimination
Time frame: Six months after reconstruction or later
Semmes-Weinstein-Monofilament test
Time frame: Six months after reconstruction or later
4 secondary outcomes
Age
Time frame: Baseline
Gap length
Time frame: Baseline
Time of reconstruction
Time frame: Baseline
Concomitant injuries
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Peripheral Nerve Injury Upper Limb, run by BG Trauma Center Tuebingen.
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 1 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: finished, as of the sponsor's last update on 9 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Two-point discrimination (time frame: Six months after reconstruction or later). 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 9 Mar 2021.