Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

Our selection criteria in this study included a patient with PDN in a scarred wound bed or poor coverage, a PDN located between the middle of the distal phalanx and the palmar digital crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length. The exclusion criteria included a PDN in healthy soft tissue, a digital nerve defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb neuroma. A finger with a small distal end of the digital nerve was also excluded, because neurorrhaphy was extremely difficult in this situation.

• Pedicled nerve flap (Device), also known as Surgical flap, Island flap: This nerve flap is a vascularized nerve graft

Primary outcomes

• Static 2-point Discrimination Test [20-26 months postoperatively]: The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.

Secondary outcomes

• Cold Intolerance Severity Score (CISS) Questionnaire [20-26 months postoperatively]: 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.

Other outcomes

• Tinel's Sign [20-26 months postoperatively]: Tinel's sign was graded 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

Sex: All, ages: 15 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* a patient with PDN in a scarred wound bed or poor coverage
* a PDN located between the middle of the distal phalanx and the palmar digital crease
* a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length

Exclusion Criteria:

* a PDN in healthy soft tissue
* a digital nerve defect longer than 3 cm
* injury to the course of the pedicle or the donor nerve
* a thumb neuroma

Participant flow

Outcome results

• Static 2-point Discrimination Test (Primary), Mean, mm: New Surgical Treatment 7.3 +/- 2.0
• Cold Intolerance Severity Score (CISS) Questionnaire (Secondary)
• Tinel's Sign (Other pre specified)

Adverse events

Time frame: 1 year

• Results publication: Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73. PMID 1262369
• Results publication: Tupper JW, Booth DM. Treatment of painful neuromas of sensory nerves in the hand: a comparison of traditional and newer methods. J Hand Surg Am. 1976 Sep;1(2):144-51. doi: 10.1016/s0363-5023(76)80008-1. PMID 1032972

• Gang Zhao, MD., Study chair, The Second Hospital of Tangshan