Sensory RecoveryNCT01958632
Muscle-in-vein Conduits for Digital Nerve Reconstruction
An observational study of Sensory Recovery, run by BG Trauma Center Tuebingen at 1 site in Germany.
Trial summary
The actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Sensory Recovery
- What is being tested?
- Nerve reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Jun 2013
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- complete digital nerve injuries, nerve reconstruction in the first 6 months post trauma
Who cannot join
- total or subtotal amputations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sensory Recovery After Reconstruction of Digital Nerves of the Hand Using Muscle-in-vein Conduits in Comparison to Nerve Suture or Nerve Transplantation
The actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture.
- Conditions
- Sensory Recovery
- Being tested
- Nerve reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve reconstructionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| N | nerve suture Receives: Procedure: Nerve reconstruction | |
| NT | nerve transplantation Receives: Procedure: Nerve reconstruction | |
| VM | vein-in-muscle conduit Receives: Procedure: Nerve reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semmes-Weinstein-Monofilament test
Measured: The earliest 6 months post-OP
Secondary outcomes (1)
Two-point-discrimination
Measured: The earliest 6 months post-OP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory RecoveryStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- BG Trauma Center Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Theodora Manoli, BG Trauma Center Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958632
- Sponsor's protocol ID
- 117/2012BO2
- Status last verified
- Oct 2013
- First submitted
- 5 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sensory Recovery After Reconstruction of Digital Nerves of the Hand Using Muscle-in-vein Conduits in Comparison to Nerve Suture or Nerve Transplantation
- ClinicalTrials.gov ID
- NCT01958632
- Acronym / sponsor ID
- 117/2012BO2
- Conditions
- Sensory Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- BG Trauma Center TuebingenUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- First posted
- 9 Oct 2013 (estimated)
- 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 actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N | – | Procedure: Nerve reconstructionnerve suture |
| NT | – | Procedure: Nerve reconstructionnerve transplantation |
| VM | – | Procedure: Nerve reconstructionvein-in-muscle conduit |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- complete digital nerve injuries, nerve reconstruction in the first 6 months post trauma
Key exclusion criteria (1 listed)
- total or subtotal amputations
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 reconstruction | Procedure or surgery | N, NT, VM |
Primary outcome
Semmes-Weinstein-Monofilament test
Time frame: The earliest 6 months post-OP
1 secondary outcome
Two-point-discrimination
Time frame: The earliest 6 months post-OP
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 Oct 2013.
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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.
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 Sensory Recovery, run by BG Trauma Center Tuebingen at 1 site in Germany.
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 1 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 Oct 2013. 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 Germany. 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?
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?
Semmes-Weinstein-Monofilament test (time frame: The earliest 6 months post-OP). 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 Oct 2013.