Nerve InjuryNCT01528397
Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft
A study testing pedicled nerve graft in people with Nerve Injury, run by The Second Hospital of Tangshan.
Trial summary
A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory loss which can result in functional disability. This article reports the treatment of the thumb PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Nerve Injury
- What is being tested?
- pedicled nerve graft
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- May 2005to May 2010
- Phase
- Interventional
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- thumb PDN defects between the middle of the distal phalanx and the metacarpophalangeal joint;
- PDN defects of single or both sides;
- PDN defects 1-4 cm in length.
Who cannot join
- injury to the course of the pedicle or the donor sites;
- PDN defects less than 1 cm or longer than 4 cm;
- no Doppler sound at the location of the second dorsal metacarpal artery (SDMA).
About this study
A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory loss which can result in functional disability. This article reports the treatment of the thumb PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN. Fourteen patients with the thumb PDN defect underwent a new surgical procedure in which the pedicled nerve graft was used to bridge nerve defect. For comparison, the investigators also collected a consecutive series of 21 patients with thumb PDN defects treated using a nonvascularized sural nerve graft. This study was designed to evaluate the efficacy of pedicled nerve grafting for PDN defects in the thumb.
Read the detailed description
At final follow-up, the investigators measured the sensibility of the thumb pulps and the donor sites using the Semmes-Weinstein monofilament test and static 2-point discrimination (2PD) test. The test points were at the centers of the radial and ulnar portions of the thumb pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
- Conditions
- Nerve Injury
- Being tested
- pedicled nerve graft
- Keywords
- defect, dorsal branch of the proper digital nerve, proper digital nerve, second dorsal metacarpal artery, pedicled nerve graft.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedicled nerve graftProcedure or surgery
Also called Vascularized nerve graft
A pedicled nerve graft harvested from the dorsal branch of the PDN can be used for reconstruction of such defects. The graft is based on the second dorsal metacarpal artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
static 2-point discrimination (2PD) test
The test points were at the centers of the radial and ulnar portions of the thumb pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMay 2005
- Primary completionSep 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528397
- Sponsor's protocol ID
- TSChen3885
- Status last verified
- Jan 2012
- First submitted
- 31 Jan 2012
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen C, Tang P, Zhang X. Reconstruction of proper digital nerve defects in the thumb using a pedicle nerve graft. Plast Reconstr Surg. 2012 Nov;130(5):1089-1097. doi: 10.1097/PRS.0b013e318267d56b.
PubMed 23096609
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft
- ClinicalTrials.gov ID
- NCT01528397
- Acronym / sponsor ID
- TSChen3885
- Conditions
- Nerve Injury
- Keywords
- defect, dorsal branch of the proper digital nerve, proper digital nerve, second dorsal metacarpal artery, pedicled nerve graft.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- May 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Feb 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.
A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory loss which can result in functional disability. This article reports the treatment of the thumb PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN. Fourteen patients with the thumb PDN defect underwent a new surgical procedure in which the pedicled nerve graft was used to bridge nerve defect. For comparison, the investigators also collected a consecutive series of 21 patients with thumb PDN defects treated using a nonvascularized sural nerve graft. This study was designed to evaluate the efficacy of pedicled nerve grafting for PDN defects in the thumb.
Detailed description
At final follow-up, the investigators measured the sensibility of the thumb pulps and the donor sites using the Semmes-Weinstein monofilament test and static 2-point discrimination (2PD) test. The test points were at the centers of the radial and ulnar portions of the thumb pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- thumb PDN defects between the middle of the distal phalanx and the metacarpophalangeal joint;
- PDN defects of single or both sides;
- PDN defects 1-4 cm in length.
Key exclusion criteria (3 listed)
- injury to the course of the pedicle or the donor sites;
- PDN defects less than 1 cm or longer than 4 cm;
- no Doppler sound at the location of the second dorsal metacarpal artery (SDMA).
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 |
|---|---|---|
| pedicled nerve graftAlso: Vascularized nerve graftA pedicled nerve graft harvested from the dorsal branch of the PDN can be used for reconstruction of such defects. The graft is based on the second dorsal metacarpal artery. | Procedure or surgery | – |
Primary outcome
static 2-point discrimination (2PD) test
Time frame: 22 months
The test points were at the centers of the radial and ulnar portions of the thumb pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
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 8 Feb 2012.
- Derived from this study: PubMed 23096609Chen C, Tang P, Zhang X. Reconstruction of proper digital nerve defects in the thumb using a pedicle nerve graft. Plast Reconstr Surg. 2012 Nov;130(5):1089-1097. doi: 10.1097/PRS.0b013e318267d56b.
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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?
A study testing pedicled nerve graft in people with Nerve Injury, run by The Second Hospital of Tangshan.
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 3 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 8 Feb 2012. 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?
static 2-point discrimination (2PD) test (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528397, which also lists 1 linked publication.
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 8 Feb 2012.