Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

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.

Study Overview

• Status: Completed
• Conditions: Neuroma
• Intervention / Treatment: Device: Neurocap®

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.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Clinique Chirurgicale Victor Hugo Paris
• Germany
  • Frankfurt am Main, Germany, 60389
    • BG Trauma Center Frankfurt am Main GmbH
• Italy
  • Milano, Italy
    • Ospedale San Guiseppe Milano
• Spain
  • Barcelona, Spain
    • Parc Sanitari Sant Joan de Déu
• Sweden
  • Goteborg, Sweden
    • Sahlgrenska University Hospital Gothenburg
  • Linkoping, Sweden
    • University Hospital Linköping
  • Malmo, Sweden
    • University Hospital Lund - Department of Hand Surgery
• United Kingdom
  • Birmingham, United Kingdom
    • Birmingham Hand Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona Center for Hand Surgery
  • California
    • Redwood City, California, United States, 94063
      • Stanford Medical Center Hand and Upper Limb Center
    • San Francisco, California, United States, 94114
      • Buncke Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Veterans affairs Medical Center Portland
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic
    • Philadelphia, Pennsylvania, United States, 19104-6061
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the neuroma.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.	Device: Neurocap®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) for Pain	Subjective pain score as indicated by the patient on a scale of 1-100.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Neuroma	Recurrence of neuroma as assessed by clinical assessment by the surgeon.	2 years
Elliot Neuroma questionnaire	Type of pain	2 years
QuickDASH	Daily functioning upper limb	2 years
Goals questionnaire	Daily functioning lower limb	2 years
Type of Pain Medication	Type of pain medication currently taken	2 years
Amount of Pain Medication	Amount of pain medication currently taken	2 years

Collaborators and Investigators

• Sponsor: Polyganics BV

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Actual): July 6, 2018
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nerve Sheath Neoplasms; Neuroma
• Other Study ID Numbers: CR-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No