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

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.

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.

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.

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.

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

Gross Hand Strength is defined as the measurement of hand strength using a dynamometer, recorded in kilograms (kg). Strength will be assessed for both the injured hand and the contralateral hand, with results recorded for each hand. This endpoint will be evaluated at 3-months, 6-months and 12-months post-index procedure.

Thumb Strength Assessment is defined as the measurement of thumb strength using a Jamar Dynamometer, recorded in kilograms (kg). Strength will be assessed for both the injured hand and the contralateral hand. This endpoint will be evaluated at 3-months, 6-months and 12-months post-index procedure.

Range of Motion (ROM) is defined as whether the injured finger achieves full flexion and extension compared to the unaffected side. This endpoint will be evaluated at 3-months, 6-months, and 12-months post-index procedure.

The Kapandji Score will be defined as a measure of thumb opposition, with scores ranging from 0 to 10, where a higher score indicates better thumb mobility and function. Results from each time point will be used to assess changes in thumb opposition and overall hand function. Assessments will be made at 3-months, 6-months and 12-months post-index procedure

The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire will be used to assess the participants' upper limb function, specifically related to the arm, shoulder, and hand. It measures the severity of symptoms and the impact of musculoskeletal disorders or injuries on daily activities. The DASH questionnaire consists of 30 items covering aspects like physical function, symptoms, and social or work-related limitations. The score ranges from 0 to 100. A higher score indicating greater disability or dysfunction. This questionnaire will be administered to each participant either on paper or electronically at the 3-month, 6-month, and 12-month follow-up visits. The DASH questionnaire will be completed individually by each participant.

The DASH Questionnaire will assess the physical function and symptoms (such as pain and weakness) of the arm, shoulder, and hand, evaluating the participant's ability to perform daily activities. These functio