Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 14
- 主要终点
- Safety data (Serious adverse events )
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible according to the following criteria:
- •Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- •Subjects who are > 18 years year old.
- •Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
- •Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
- •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.
- •Subjects with history of pain in the area of the end-neuroma for at least 6-months.
- •Subjects with a positive Tinel's sign.
排除标准
- •Subjects who meet any of the following criteria will be excluded from participation:
- •Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
- •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.
- •Subjects who have had historical radiotherapy in the area of the end-neuroma.
- •Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
- •Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
- •Subjects is involved in another pain study.
- •Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
- •Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
- •Insufficient soft tissue at the end-neuroma site to cover the investigational device.
- •Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.
研究组 & 干预措施
Nerve Capping Device
Implant with the experimental device
干预措施: Nerve Capping Device (Device)
结局指标
主要结局
Safety data (Serious adverse events )
时间窗: 6 weeks
Serious adverse events related to the investigation device as determine by independent expert.
Effectiveness (VAS score)
时间窗: 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.
Effectiveness (QuickDASH score)
时间窗: 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.
Effectiveness (Quantity and class of pain medication used)
时间窗: 6 weeks
Quantity and class of pain medication used for the end-neuroma pain at 6-week follow-up compared to baseline
次要结局
- Safety (Rate of serious adverse device effects)(3, 6 and 12 months)
- Effectiveness (VAS score)(3, 6, 12 months)
- Effectiveness (QuickDASH score)(3, 6, 12 months)
- Effectiveness (DN4 score)(6 weeks, 3, 6, 12 months)
- Effectiveness (Elliot score)(6 weeks, 3, 6, 12 months)
- Effectiveness (Quantity and class of pain medication used)(3, 6, 12 months)
- Rate of recurrence of symptomatic neuroma(12 months)