Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

• Device description NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
• Objective This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
• Study design This post-market surveillance study consists of a cohort study to provide post market surveillance information regarding long-term performance and ease of use of the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in the upper and lower extremity. Sub analyses will be performed regarding demographics and medical background.

Inclusion criteria

• Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
• Subjects who are able to comply with the follow-up or other requirements.
• Subjects who are ≥ 18 years old.
• Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
• Subjects with a positive Tinel's sign.
• Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS questionnaire score.
• Subjects that are indicated for surgery to treat symptomatic neuroma.

Exclusion criteria

• Subjects who do not complete the informed consent.
• Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
• Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
• Subjects with congenital neuropathy.
• Insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. Use of the device over a joint is advised against.
• Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
• Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-ε-Caprolactone) (PLCL).
• Proximal nerve end > 8mm.
• Pregnancy.