Sensory Restoration of the Reconstructed Finger PulpsNCT01559337
Nerve Transfer for Finger Sensory Reconstruction With Dorsal Branch of the Digital Nerve
A study testing Nerve transfer in people with Sensory Restoration of the Reconstructed Finger Pulps and Cold Intolerance of the Reconstructed Finger, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger pulp, which results in functional disability.The dorsal branch of the PDN can be transferred for reconstruction of such nerve defects.In this study, the investigators modified the Lesavoy et al' technique and evaluated the… Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Sensory Restoration of the Reconstructed Finger Pulps, Cold Intolerance of the Reconstructed Finger, Pain of the Reconstructed Finger
- What is being tested?
- Nerve transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- May 2007to Jan 2012
- 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 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Finger PDN defects proximal to the proximal interphalangeal joint
- Single or two PDN defects
- PDN defects longer than 1 cm.
Who cannot join
- PDN defects less than 1 cm
- Concomitant injuries to the multiple dorsal sensory branches that preclude their use as nerve donor sites
- Thumb PDN defects.
Trial locations and contacts
1 site in 1 country.
About this study
A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger pulp, which results in functional disability.The dorsal branch of the PDN can be transferred for reconstruction of such nerve defects.In this study, the investigators modified the Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for PDN defects. For comparison, the investigators collected a consecutive series of 32 patients with finger PDN defects treated using a traditional sural nerve graft from February 2005 to October 2008.
- Conditions
- Sensory Restoration of the Reconstructed Finger Pulps, Cold Intolerance of the Reconstructed Finger, Pain of the Reconstructed Finger
- Being tested
- Nerve transfer
- Keywords
- defect, dorsal branch of the proper digital nerve, proper digital nerve, nerve transfer, finger sensory reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve transferProcedure or surgery
Also called Local pedicle nerve transfer
the dorsal branch was used as a pedicle nerve for reconstructing PDN defects
| Study group | Role | What they receive |
|---|---|---|
| Nerve repair | Other | the dorsal branch of the proper digital nerve was used as a pedicle nerve for reconstructing PDN defects Receives: Procedure: Nerve transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
static 2-point discrimination (2PD) test
At final follow-up, we measured the sensibility of the pulps and the donor sites using the static 2-point discrimination (2PD) test. The test points were at the center of the radial or ulnar portion of the 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: 26 months
Secondary outcomes (1)
self-administered Cold Intolerance Severity Score (CISS) questionnaire
The maximum score was 100 and was grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Restoration of the Reconstructed Finger PulpsStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peifu Tang, MD., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559337
- Sponsor's protocol ID
- CHEN-19750471
- Status last verified
- Mar 2012
- First submitted
- 19 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Transfer for Finger Sensory Reconstruction With Dorsal Branch of the Digital Nerve
- ClinicalTrials.gov ID
- NCT01559337
- Acronym / sponsor ID
- CHEN-19750471
- Conditions
- Sensory Restoration of the Reconstructed Finger Pulps, Cold Intolerance of the Reconstructed Finger, Pain of the Reconstructed Finger
- Keywords
- defect, dorsal branch of the proper digital nerve, proper digital nerve, nerve transfer, finger sensory reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Mar 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 causes partial or complete sensory loss of the finger pulp, which results in functional disability.The dorsal branch of the PDN can be transferred for reconstruction of such nerve defects.In this study, the investigators modified the Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for PDN defects. For comparison, the investigators collected a consecutive series of 32 patients with finger PDN defects treated using a traditional sural nerve graft from February 2005 to October 2008.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve repair | Other | Procedure: Nerve transferthe dorsal branch of the proper digital nerve was used as a pedicle nerve for reconstructing PDN defects |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Finger PDN defects proximal to the proximal interphalangeal joint
- Single or two PDN defects
- PDN defects longer than 1 cm.
Key exclusion criteria (3 listed)
- PDN defects less than 1 cm
- Concomitant injuries to the multiple dorsal sensory branches that preclude their use as nerve donor sites
- Thumb PDN defects.
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 transferAlso: Local pedicle nerve transferthe dorsal branch was used as a pedicle nerve for reconstructing PDN defects | Procedure or surgery | Nerve repair |
Primary outcome
static 2-point discrimination (2PD) test
Time frame: 26 months
At final follow-up, we measured the sensibility of the pulps and the donor sites using the static 2-point discrimination (2PD) test. The test points were at the center of the radial or ulnar portion of the 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.
1 secondary outcome
self-administered Cold Intolerance Severity Score (CISS) questionnaire
Time frame: 26 months
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 21 Mar 2012.
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.
Peifu Tang, MD. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve transfer in people with Sensory Restoration of the Reconstructed Finger Pulps and Cold Intolerance of the Reconstructed Finger, run by The Second Hospital of Tangshan at 1 site in China.
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 21 Mar 2012. 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 China. 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?
static 2-point discrimination (2PD) test (time frame: 26 months). 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 21 Mar 2012.