Clinical trial NCT02993276: Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Official title: Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroma
Lead sponsor: Polyganics BV
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the neuroma.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: 2 years
Secondary outcomes:
measure: Recurrence of Neuroma
timeFrame: 2 years
measure: Elliot Neuroma questionnaire
timeFrame: 2 years
measure: QuickDASH
timeFrame: 2 years
measure: Goals questionnaire
timeFrame: 2 years
measure: Type of Pain Medication
timeFrame: 2 years
measure: Amount of Pain Medication
timeFrame: 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Center for Hand Surgery
state: Arizona
city: Redwood City
country: United States
facility: Stanford Medical Center Hand and Upper Limb Center
state: California
city: San Francisco
country: United States
facility: Buncke Clinic
state: California
city: Portland
country: United States
facility: Veterans affairs Medical Center Portland
state: Oregon
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Paris
country: France
facility: Clinique Chirurgicale Victor Hugo Paris
city: Frankfurt am Main
country: Germany
facility: BG Trauma Center Frankfurt am Main GmbH
city: Milano
country: Italy
facility: Ospedale San Guiseppe Milano
city: Barcelona
country: Spain
facility: Parc Sanitari Sant Joan de Deu
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital Gothenburg
city: Linkoping
country: Sweden
facility: University Hospital Linköping
city: Malmo
country: Sweden
facility: University Hospital Lund - Department of Hand Surgery
city: Birmingham
country: United Kingdom
facility: Birmingham Hand Centre
Study officials:
References: