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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Gold Coast University Hospital
Gold Coast, Queensland, Australia
Cumulative incidence of complications (CIC) related to the investigational device
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)
Time frame: through 12-months post-procedure
Semmes-Weinstein monofilament (SWMF) for nerve functional recovery
Product performance will be assessed as functional nerve repair based on nerve functional recovery using Semmes-Weinstein monofilament (SWMF) at 6-months post-surgery
Time frame: at 6 months post-procedure
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