A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair

MMI (Medical Microinstruments, Inc.)100 enrolled

Overview

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical nerve coaptation, following nerve injuries to the hand. This study will include participants with traumatic sensory nerve lesions of a finger nerve distal to the carpal tunnel who are treated with nerve suturing. The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure. The primary safety endpoint is the intraoperative serious adverse event rate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Nerve Injury Peripheral Nerve Injuries

Interventions

Robotic-assisted surgery consists of participants who undergo nerve coaptation with the Symani Surgical System, according to the Instruction for Use (IFU). In order for the surgery to be considered a robotic assisted surgery, the participants must be randomized to the RAS group which will include: * Participants where all nerve coaptations were performed entirely with Symani. * Participants who underwent a hybrid procedure, where a coaptation was commenced using Symani but a switch to manual suturing occurred during the procedure

Manual SurgeryPROCEDURE

Manual surgery consists of participants who undergo nerve coaptation through manual techniques by a surgeon using handheld instruments without robotic assistance. In order for the surgery to be considered a manual surgery, the participants must be randomized to the MS group which will include: * Participants where all nerve coaptations were performed entirely manually. * Participants who underwent a hybrid procedure, where a coaptation was commenced using manual suturing but a switch to Symani occurred during the procedure.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Pre-Operative Inclusion Criteria: 1. Adults, at the time of nerve injury aged from 18 to 70 years 2. Patient agrees to participate in the study, returns for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study and its requirements 3. Complete loss of a nerve-specific receptive field of the finger 4. Patient with a clinical indication for a microsurgical nerve coaptation in nerve injury that can be repaired by end-to-end suturing 5. Patient with traumatic transection of one or more digit nerves distal to the carpal tunnel with sensory autonomous innervation areas on the finger or thumb tips 6. Investigator considers candidate acceptable for either conventional epineural suturing or robotic-assisted epineural suturing 7. The injury was treated within 10 days Exclusion Criteria: 1. Patients who are not capable and/or unwilling to provide informed consent 2. Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators' discretion. 3. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes 4. Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator 5. Indication for bilateral nerve repair 6. Known impaired sensibility of the injured finger 7. Patients with implanted pacemaker 8. Replantation which includes bones Intra-Operative Inclusion Criteria Individuals will be included in the study if the following criteria are met intraoperatively: 1\. Verification of a sensory nerve lesion without a gap and presence of a nerve that could be sutured in end-to-end fashion Intra-Operative Exclusion Criteria Individuals will be excluded from participating in this study if any of the following criteria are met intraoperatively: 1\. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would

Outcomes

Primary Outcomes

Two-point discrimination (2PD) test, at 6-months post index procedure.

The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure. The two-point discrimination test is a sensory test used to assess the ability of the patient to distinguish between two distant points of touch on the skin. The test measures the minimum distance between two stimulus points on the skin, which are perceived as distinct points. This endpoint will be evaluated at 6-months post index procedure.

Time frame: From participants index procedure through 6-months post index procedure

Intraoperative serious adverse event rate

The primary safety endpoint is the intraoperative serious adverse event rate. The incidence of SAEs occurring during the intra-operative period will be presented. In addition, each participant will be categorized as 'had any SAEs in the intra-operative period' Yes or No. The proportion of participants who experienced any SAEs in the intra-operative period will be presented with exact confidence limits. The difference between groups will also be presented with exact confidence limits.

Time frame: The duration of the participants index procedure.

Secondary Outcomes

Two-point discrimination test at 3 and 12-months post index procedure

The two-point discrimination test (2PD) will be assessed at 3, 6, 12-months post-surgery. It will be measured in mm. Descriptive statistics will be presented by surgical group and timepoint. A mixed model for repeated measures (MMRM) will be fitted with 2PD (mm) as the outcome and surgical group, timepoint and surgical group\*timepoint as fixed effects. Timepoint will be included as a repeated term (subject=participant) to acknowledge the repeated measures in the study (i.e. a participant will have data for 3, 6, and 12-months). Nerve will also be included as a repeated term (subject=participant) to acknowledge that a participant may have more than one nerve involved. Other terms may be included, as defined in the SAP. From the model the least squares means (LSM) for each surgical group at each timepoint will be presented with confidence limits (CLs). In addition, the difference in LSMs between groups at each timepoint will be presented with CL.

Time frame: From participants index procedure through 3-months and 12-months post-index procedure

Ten Test on sensitivity at 3, 6 and-12 months post index procedure

Ten Test is defined as the assessment of sensory function in the injured and contralateral nerves, using a scale from 0 (no sensitivity) to 10 (full sensitivity). The results will be compared between the injured and contralateral nerves to evaluate sensory function. This endpoint will be evaluated at 3-months, 6-months and 12-months post-index procedure.

Time frame: From participants index procedure through 3-months and 12-months post-index procedure

Sensory reinnervation assessment (Semmes-Weinstein monofilament method) at 3, 6 and-12 months post index procedure

Sensory Reinnervation is defined as the smallest filament detected on both the affected and contralateral nerves using the Semmes-Weinstein Monofilament Test. The endpoint will be evaluated at 3-months, 6-months, and 12-months post-index procedure