Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section

This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.

Study Overview

• Status: Completed
• Conditions: Neuroma
• Intervention / Treatment: Device: Nerve Capping Device

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, F-67493
    • Strasbourg University Hospitals
• Netherlands
  • Den Haag, Netherlands, 2545 CH
    • Haga hospital
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Hospital
  • Groningen, Netherlands, 9713GZ
    • UMCG
  • Groningen, Netherlands, 9728 NT
    • Martini Hospital Groningen
  • Lelystad, Netherlands, 8233AA
    • MC Groep
  • Maastricht, Netherlands, 6229 HX
    • MUMC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Subjects will be eligible according to the following criteria:

1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Subjects who are > 18 years year old.
3. Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
4. Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
5. Symptomatic neuroma confirmed by pain relief following a 10min ±2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as any reduction in VAS questionnaire score.
6. Subjects with history of pain in the area of the end-neuroma for at least 6-months.
7. Subjects with a positive Tinel's sign.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation:

1. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
2. Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation or subjects who are not using appropriate birth control.
3. Subjects who have had historical radiotherapy in the area of the end-neuroma.
4. Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
5. Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
6. Subjects is involved in another pain study.
7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
8. Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
9. Insufficient soft tissue at the end-neuroma site to cover the investigational device.
10. Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve Capping Device; Implant with the experimental device	Device: Nerve Capping Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety data (Serious adverse events )	Serious adverse events related to the investigation device as determine by independent expert.	6 weeks
Effectiveness (VAS score)	Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) at 6-week follow-up compared to score at baseline.	6 weeks
Effectiveness (QuickDASH score)	Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) at 6-week follow-up compared to score at baseline.	6 weeks
Effectiveness (Quantity and class of pain medication used)	Quantity and class of pain medication used for the end-neuroma pain at 6-week follow-up compared to baseline	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Rate of serious adverse device effects)	Rate of serious adverse device effects as determined by the physician and independent expert.; Reduction of pain caused by symptomatic neuroma after 3 months, 6 months and 12 months following the procedure, as compared to pain before the procedure.; Improvement of quality of life at 3 months, 6 months and 12 months follow-up, as compared to the quality of life before the procedure.; ≤20% recurrence of symptomatic neuroma within 12 months.; Reduction of pain medication used to treat neuroma pain at 3 months, 6 months and 12 months, as compared to the quantity pain medication used for the neuroma pain before the procedure.	3, 6 and 12 months
Effectiveness (VAS score)	Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) compared to score at baseline.	3, 6, 12 months
Effectiveness (QuickDASH score)	Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) compared to score at baseline.	3, 6, 12 months
Effectiveness (DN4 score)	Pain caused by symptomatic end-neuroma: DN4 score (10 y/n items characterising pain) compared to score at baseline.	6 weeks, 3, 6, 12 months
Effectiveness (Elliot score)	Pain caused by symptomatic end-neuroma: Elliot score (5 items rated 0 (no pain) to 4 (pain intolerable)) compared to score at baseline.	6 weeks, 3, 6, 12 months
Effectiveness (Quantity and class of pain medication used)	Quantity and class of pain medication used for the neuroma pain at 3, 6 and 12 months	3, 6, 12 months
Rate of recurrence of symptomatic neuroma	defined as daily pain combined with increased used of pain medication compared to baseline and no improvement in QuickDASH score, but pain is relieved with Xylocaine nerve block.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability (User Device Handling Questionnaire)	Ease of placement of the device assessed via User Device Handling Questionnaire.	Day 0

Collaborators and Investigators

• Sponsor: Polyganics BV
• Investigators: Study Chair: Betty IJmker, MSc, Polyganics BV

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

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: 034A01_CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED