Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- The primary clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD).
研究概览
简要总结
This is a prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.
详细描述
Integra NeuraGen Nerve Guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. Integra NeuraGen Nerve Guide is used in this registry as a comparator to a next-generation advanced nerve guide, Integra NeuraGen 3D Nerve Guide Matrix, that is based on the original Integra NeuraGen Nerve Guide technology but contains a regenerative matrix in the lumen.
Centers chosen for participation will be current users of Integra's collagen nerve gap repair products listed above.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject has undergone nerve gap repair utilizing NeuraGen or NeuraGen 3D
- •Subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc.
- •Subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol.
- •Subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand.
- •Subject requires only a single repair per proper digital nerve branch
排除标准
- •Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
- •Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.
- •Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve
- •Subject has debris due to injury of the affected hand where contamination cannot be ruled out.
- •Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome)
- •Subject has an infection of the area around the nerve defect.
- •Subjects with diagnosed Peripheral Vascular Disease and Peripheral Arterial Disease
- •Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.
- •Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.
- •Subject has a history of injury to or a congenital abnormality of the target or contralateral hand or limb which may impact nerve healing or confound study results.
结局指标
主要结局
The primary clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD).
时间窗: 18 Months
The primary endpoint success is when each subject reaches meaningful recovery, which is defined as an MRC score of S3+ or S4 (fair, good or excellent 2PD) of the pulp assessment of the distal phalanx of the affected digit(s).
次要结局
- Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device(18 Months)
- Evaluation of Moving 2PD using DeMayo 2-point discrimination device(18 months)
- Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)(15 Months)
- Evaluation of Visual Analog Scale for Pain (VAS)(15 Months)