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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Strasbourg University Hospitals
Strasbourg, France
Albert Schweitzer Hospital
Dordrecht, Netherlands
UMCG
Groningen, Netherlands
Martini Hospital Groningen
Groningen, Netherlands
MC Groep
Lelystad, Netherlands
MUMC
Maastricht, Netherlands
Haga Hospital
The Hague, Netherlands
Safety data (Serious adverse events )
Serious adverse events related to the investigation device as determine by independent expert.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 12 months
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