Neuroma
Conditions
Brief summary
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro) 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.
Detailed description
1. 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). 2. 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. 3. 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.
Interventions
DEVICENeurocap®
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.
Sponsors
Polyganics BV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation. 2. Subjects who are able to comply with the follow-up or other requirements. 3. Subjects who are ≥ 18 years old. 4. Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb. 5. Subjects with a positive Tinel's sign. 6. 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. 7. Subjects that are indicated for surgery to treat symptomatic neuroma.
Exclusion criteria
1. Subjects who do not complete the informed consent. 2. Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization). 3. Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months. 4. Subjects with congenital neuropathy. 5. 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. 6. Subjects who have had historical radiotherapy in the area of the (end-) neuroma. 7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32\[15/85 D/L\] Lactide-ε-Caprolactone) (PLCL). 8. Proximal nerve end \> 8mm. 9. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | 2 years | Subjective pain score as indicated by the patient on a scale of 1-100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elliot Neuroma questionnaire | 2 years | Type of pain |
| QuickDASH | 2 years | Daily functioning upper limb |
| Recurrence of Neuroma | 2 years | Recurrence of neuroma as assessed by clinical assessment by the surgeon. |
| Type of Pain Medication | 2 years | Type of pain medication currently taken |
| Amount of Pain Medication | 2 years | Amount of pain medication currently taken |
| Goals questionnaire | 2 years | Daily functioning lower limb |
Countries
France, Germany, Italy, Spain, Sweden, United Kingdom, United States
Outcome results
None listed