Digital Nerve Injury
Conditions
Keywords
nerve repair, digital nerve repair, digital nerve lesion, peripheral nerve injury, peripheral nerve lesion, peripheral nerve repair
Brief summary
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.
Interventions
DEVICETISSIUM™ Nerve Coaptation Device
Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.
Sponsors
Tissium
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient undergoing a repair of a proper digital nerve of the hand; * 100% transection injury to the nerve under repair; * Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension; * Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures; * Patient willing and able to provide a signed Patient Informed Consent Form; * Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.
Exclusion criteria
* Patient has a known allergy to the constituent polymer of the investigational device; * Patient has a documented diagnosis of peripheral neuropathy; * Patient has a history of neuropathic pain; * Patient has a history of injury to the nerve being studied; * Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area); * Patient is pregnant or nursing * Any patient with a diagnosis of type 1 Diabetes Mellitus;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of complications (CIC) related to the investigational device | through 12-months post-procedure | CIC includes the occurrence of any of the following complications: * Infection * Chronic pain (defined as pain lasting more than 3 months) not otherwise specified * Excessive inflammation as determined by the investigator * Device extrusion * Symptomatic neuroma formation * Impaired wound healing (examples are dehiscence, pain, skin irritation, keloid, scar hypertrophy) * Allergic reaction to the constituent polymer of the investigational device * Serious Adverse Device Effect (SADEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semmes-Weinstein monofilament (SWMF) for nerve functional recovery | at 6 months post-procedure | Product performance will be assessed as functional nerve repair based on nerve functional recovery using Semmes-Weinstein monofilament (SWMF) at 6-months post-surgery |
Countries
Australia
Outcome results
None listed