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Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

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ClinicalTrials.gov Identifier: NCT02528266
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Polyganics BV

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuroma Device: Nerve Capping Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Arm Intervention/treatment
Experimental: Nerve Capping Device
Implant with the experimental device
Device: Nerve Capping Device



Primary Outcome Measures :
  1. Safety data (Serious adverse events ) [ Time Frame: 6 weeks ]
    Serious adverse events related to the investigation device as determine by independent expert.

  2. Effectiveness (VAS score) [ Time Frame: 6 weeks ]
    Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) at 6-week follow-up compared to score at baseline.

  3. Effectiveness (QuickDASH score) [ Time Frame: 6 weeks ]
    Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) at 6-week follow-up compared to score at baseline.

  4. Effectiveness (Quantity and class of pain medication used) [ Time Frame: 6 weeks ]
    Quantity and class of pain medication used for the end-neuroma pain at 6-week follow-up compared to baseline


Secondary Outcome Measures :
  1. Safety (Rate of serious adverse device effects) [ Time Frame: 3, 6 and 12 months ]

    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.

  2. Effectiveness (VAS score) [ Time Frame: 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) compared to score at baseline.

  3. Effectiveness (QuickDASH score) [ Time Frame: 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) compared to score at baseline.

  4. Effectiveness (DN4 score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: DN4 score (10 y/n items characterising pain) compared to score at baseline.

  5. Effectiveness (Elliot score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: Elliot score (5 items rated 0 (no pain) to 4 (pain intolerable)) compared to score at baseline.

  6. Effectiveness (Quantity and class of pain medication used) [ Time Frame: 3, 6, 12 months ]
    Quantity and class of pain medication used for the neuroma pain at 3, 6 and 12 months

  7. Rate of recurrence of symptomatic neuroma [ Time Frame: 12 months ]
    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.


Other Outcome Measures:
  1. Usability (User Device Handling Questionnaire) [ Time Frame: Day 0 ]
    Ease of placement of the device assessed via User Device Handling Questionnaire.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528266


Locations
France
Strasbourg University Hospitals
Strasbourg, France, F-67493
Netherlands
Haga Hospital
Den Haag, Netherlands, 2545 CH
Albert Schweitzer Hospital
Dordrecht, Netherlands, 3318 AT
UMCG
Groningen, Netherlands, 9713GZ
Martini Hospital Groningen
Groningen, Netherlands, 9728 NT
MC Groep
Lelystad, Netherlands, 8233AA
MUMC
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Polyganics BV
Investigators
Study Chair: Betty IJmker, MSc Polyganics BV

Responsible Party: Polyganics BV
ClinicalTrials.gov Identifier: NCT02528266     History of Changes
Other Study ID Numbers: 034A01_CIP
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms