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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve Capping Device | Experimental | Implant with the experimental device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Capping Device | Device |
|
| 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 |
| 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability (User Device Handling Questionnaire) | Ease of placement of the device assessed via User Device Handling Questionnaire. | Day 0 |
Inclusion Criteria:
Subjects will be eligible according to the following criteria:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participation:
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| Name | Affiliation | Role |
|---|---|---|
| Betty IJmker, MSc | Polyganics BV | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strasbourg University Hospitals | Strasbourg | F-67493 | France | |||
| Albert Schweitzer Hospital |
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| ID | Term |
|---|---|
| D009463 | Neuroma |
| ID | Term |
|---|---|
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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 |
| Dordrecht |
| 3318 AT |
| Netherlands |
| UMCG | Groningen | 9713GZ | Netherlands |
| Martini Hospital Groningen | Groningen | 9728 NT | Netherlands |
| MC Groep | Lelystad | 8233AA | Netherlands |
| MUMC | Maastricht | 6229 HX | Netherlands |
| Haga Hospital | The Hague | 2545 CH | Netherlands |