Clinical trial NCT05339594: REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
Official title: Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Nerve Injuries
Keywords: Digital Nerve Gap Repair
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects with have had a repair of a peripheral nerve injury in the upper extremity distal to the palmer crease of the hand and without previous repairs.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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).
timeFrame: 18 Months
Secondary outcomes:
measure: Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device
timeFrame: 18 Months
measure: Evaluation of Moving 2PD using DeMayo 2-point discrimination device
timeFrame: 18 months
measure: Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)
timeFrame: 15 Months
measure: Evaluation of Visual Analog Scale for Pain (VAS)
timeFrame: 15 Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
city: Saint Louis
country: United States
facility: Washington University at St Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Integra LifeSciences
name: Maria Leonard, BSN,RN,CTBS
role: STUDY_DIRECTOR
References: