- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559337
Nerve Transfer for Finger Sensory Reconstruction With Dorsal Branch of the Digital Nerve
March 20, 2012 updated by: The Second Hospital of Tangshan
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Tangshan, Hebei, China, 063000
- Ethetic Committee of Tangshan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 50 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Finger PDN defects proximal to the proximal interphalangeal joint
- Single or two PDN defects
- PDN defects longer than 1 cm.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Nerve repair
the dorsal branch of the proper digital nerve was used as a pedicle nerve for reconstructing PDN defects
|
the dorsal branch was used as a pedicle nerve for reconstructing PDN defects
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
26 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-administered Cold Intolerance Severity Score (CISS) questionnaire
Time Frame: 26 months
|
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.
|
26 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peifu Tang, MD., Chinese PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
March 19, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (ESTIMATE)
March 21, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 21, 2012
Last Update Submitted That Met QC Criteria
March 20, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHEN-19750471
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sensory Restoration of the Reconstructed Finger Pulps
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedSensory Reconstruction of the Volar Aspect of the Finger | The Heterodigital Neurocutaneous Island FlapChina
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedSoft Tissue Defect of the FingerChina
-
Galderma R&DCompletedVolume Restoration and Shaping of the ButtocksBelgium, Spain, Sweden
-
BG UnfallklinikUnknownTraumatic Lesion of Sensory Nerves of the HandGermany
-
Assiut UniversityCompletedUS-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge NeedleEgypt
-
University Hospital MuensterCompletedCompensate the Roughness of the Skin | Compensate the Sensory SymptomsGermany
-
Duke UniversityNational Institute of Allergy and Infectious Diseases (NIAID); The Miriam Hospital and other collaboratorsCompletedCharacterize Gel Distribution in the Vagina | Study Women's Sensory Perceptions and Preferences of GelUnited States
-
Charite University, Berlin, GermanyAesculap AGUnknownRevision Total Knee Arthroplasty Because of | Loosening | Instability | Impingement | or Other Reasons Accepted as Indications for TKA Exchange. | The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee ArthroplastyGermany
-
Cairo UniversityUnknownthe Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic BlocksEgypt
-
AZ Sint-Jan AVRecruitingQuality of Life | Mandibular Reconstruction | Benign or Malignant Tumour of the Oral Cavity | Stage III-IV Osteonecrosis | Fixed Dental RestorationBelgium
Clinical Trials on Nerve transfer
-
Dr. Soetomo General HospitalUnknownBrachial Plexus NeuropathiesIndonesia
-
University of AlbertaCanadian Institutes of Health Research (CIHR)Completed
-
Washington University School of MedicineUnited States Department of DefenseCompleted
-
Huashan HospitalCompleted
-
The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
-
Lawson Health Research InstituteDr Christopher Doherty; Dr Thomas MillerCompletedSevere Compressive Ulnar Nerve Neuropathy (McGowan Grade III)
-
Siriraj HospitalLerdsin General HospitalCompleted
-
Assiut UniversityRecruiting
-
Burke Medical Research InstituteMassachusetts General HospitalRecruitingSpinal Cord Injuries | Cervical Spinal Cord Injury | TetraplegiaUnited States
-
Aristotle University Of ThessalonikiRecruitingChronic Low-back Pain | Physical Therapy | Hamstring Injury | Transcutaneous Electric Nerve Stimulation | Muscle; Injury, Quadriceps (Thigh) | Calf Muscle PulledGreece