Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Static 2PD test
Study Overview
Brief Summary
Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.
Detailed Description
Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger
- •the defect associated with the transected digital nerves in both sides
- •a defect greater than 1.5 cm
- •a patient aged 15 to 60 years
Exclusion Criteria
- •injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
- •injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap
- •a defect less than or equal to 1.5 cm
- •patient age < 15 years or > 60 years
Arms & Interventions
Bilaterally innervated flap
Two nerve branches attached with the flap for sensory reconstruction.
Intervention: Flap including bilateral nerve branches (Procedure)
Outcomes
Primary Outcomes
Static 2PD test
Time Frame: 18 months to 24 months after surgery
We use a Disk-Criminator to test two nearby points when touching the flap
Secondary Outcomes
No secondary outcomes reported