Peripheral Nerve Injury Digital Nerve Hand LeftNCT01573650
Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial
An observational study of Peripheral Nerve Injury Digital Nerve Hand Left, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
1. To analyse the outcome of different treatment options of peripheral nerve repair with no gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize peripheral nerve repair 2. To reduce morbidity with the same outcome Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Injury Digital Nerve Hand Left
- How many people
- 37 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2015to 7 Jul 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with traumatic peripheral nerve injury of the finger(s) who are to be treated with peripheral nerve repair at the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital of Basel Written informed consent
Who may be able to join
- Patients with traumatic peripheral nerve injury of the finger(s) who are to be treated with peripheral nerve repair at the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital of Basel
- Written informed consent
Who cannot join
- Age < 18 years
- Age > 90 years
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
- To analyse the outcome of different treatment options of peripheral nerve repair with no gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize peripheral nerve repair
- To reduce morbidity with the same outcome
Read the detailed description
Patients planned to undergo peripheral nerve repair after traumatic nerve injury with either no gap (group 1) or with a critical sized defect (>5mm, group 2) of the finger providing written informed consent to this investigation will be randomised in two groups:.
Group 1: nerve repair with no gap Group 1a (standard): Epineural Suture Group 1b (experimental): Epineural Suture and Fibrin Wrap Group 2: Nerve repair with a critical sized (>5mm) defect Group 2a (standard): Epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and Fibrin Conduit
In all groups an epineural suture will be performed (suture enhancement). The outcome of fibrin enwrapment and fibrin conduit will be compared to the standard treatment option to date (direct nerve repair and autologous nerve graft, respectively). Randomization will be performed using a computer-base algorithm (www.randomizer.at). Ambulatory follow up of patients is carried out by the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital Basel. The outcome-assessor as well as the patient will be blinded for analysis and the outcome-assessor will have no access to the surgery report.
The investigator's aim is to analyse 48 patients within 12 months. Since 100 patients undergo peripheral nerve repair annually in the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery at the University Hospital Basel, patient accrual appears unproblematic.
After completion, statistical analysis focusing on the comparison of the different types of surgery concerning the clinical parameters 2-Point Discrimination (PD), Semmes Weinstein test, and electroneurography will be conducted.
After six months, no difference will be expected between group 1a and 1b or 2a and 2b, respectively. In the investigator's experience there will be no confounders which may influence nerve regeneration. A similar patient satisfaction will be expected between the groups. The investigator expect a higher patient satisfaction in group 2b than in group 2a due to nerve tissue harvest. Between group 1a and 1b no difference is expected regarding MHQ.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Group 1a (standard): Epineural Suture Group 1b (experimental): Epineural suture and Fibrin Wrap | |
| group 2 | Group 2a (standard): Epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and Fibrin Conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-PD
Measured: 2wks, 3mts and 6mts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study start1 Mar 2015
- Primary completion7 Jul 2021
- Study completion7 Jul 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 Digital Nerve Hand LeftStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Kalbermatten, MD, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573650
- Sponsor's protocol ID
- Version 2, 01/04/2012
- Status last verified
- Nov 2021
- First submitted
- 5 Apr 2012
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT01573650
- Acronym / sponsor ID
- Version 2, 01/04/2012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 9 Apr 2012 (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.
- To analyse the outcome of different treatment options of peripheral nerve repair with no gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize peripheral nerve repair
- To reduce morbidity with the same outcome
Detailed description
Patients planned to undergo peripheral nerve repair after traumatic nerve injury with either no gap (group 1) or with a critical sized defect (>5mm, group 2) of the finger providing written informed consent to this investigation will be randomised in two groups:.
Group 1: nerve repair with no gap Group 1a (standard): Epineural Suture Group 1b (experimental): Epineural Suture and Fibrin Wrap Group 2: Nerve repair with a critical sized (>5mm) defect Group 2a (standard): Epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and Fibrin Conduit
In all groups an epineural suture will be performed (suture enhancement). The outcome of fibrin enwrapment and fibrin conduit will be compared to the standard treatment option to date (direct nerve repair and autologous nerve graft, respectively). Randomization will be performed using a computer-base algorithm (www.randomizer.at). Ambulatory follow up of patients is carried out by the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital Basel. The outcome-assessor as well as the patient will be blinded for analysis and the outcome-assessor will have no access to the surgery report.
The investigator's aim is to analyse 48 patients within 12 months. Since 100 patients undergo peripheral nerve repair annually in the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery at the University Hospital Basel, patient accrual appears unproblematic.
After completion, statistical analysis focusing on the comparison of the different types of surgery concerning the clinical parameters 2-Point Discrimination (PD), Semmes Weinstein test, and electroneurography will be conducted.
After six months, no difference will be expected between group 1a and 1b or 2a and 2b, respectively. In the investigator's experience there will be no confounders which may influence nerve regeneration. A similar patient satisfaction will be expected between the groups. The investigator expect a higher patient satisfaction in group 2b than in group 2a due to nerve tissue harvest. Between group 1a and 1b no difference is expected regarding MHQ.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –Group 1a (standard): Epineural Suture Group 1b (experimental): Epineural suture and Fibrin Wrap |
| group 2 | – | –Group 2a (standard): Epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and Fibrin Conduit |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with traumatic peripheral nerve injury of the finger(s) who are to be treated with peripheral nerve repair at the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital of Basel Written informed consent
Key inclusion criteria (2 listed)
- Patients with traumatic peripheral nerve injury of the finger(s) who are to be treated with peripheral nerve repair at the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital of Basel
- Written informed consent
Key exclusion criteria (3 listed)
- Age < 18 years
- Age > 90 years
- Pregnancy
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
2-PD
Time frame: 2wks, 3mts and 6mts
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 16 Nov 2021.
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.
Daniel Kalbermatten, MD, PhD principal investigator
University Hospital, Basel, Switzerland
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 Peripheral Nerve Injury Digital Nerve Hand Left, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 16 Nov 2021. 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 Switzerland. 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?
2-PD (time frame: 2wks, 3mts and 6mts). 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 16 Nov 2021.