Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome

This is an interventional treatment trial for Carpal Tunnel Syndrome Read More

Inclusion Criteria:

• Patient is scheduled to undergo carpal tunnel release surgery.
• Patient has chronic Carpal Tunnel Syndrome with persistent symptoms despite non-operative treatment, or refusal of non-operative treatment, with one or more of the following: splinting, NSAIDs or corticosteroid injections.
• Carpal Tunnel Syndrome must be confirmed by positive results of Electromyography (EMG) and Nerve Conduction Velocity (NCV) tests.
• Patient is a male or non-pregnant, non-lactating female.
• Patient is 18-75 years of age, inclusive.
• Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
• Patient must voluntarily provide written, informed consent.

Exclusion Criteria:

• Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand.
• Patient has a medical condition that precludes the use of anesthetic required for surgery.
• Patient has an ipsilateral injury or other conditions affecting hand function.
• Patient has acute CTS resulting from an injury (e.g., fracture).
• Patient has had previous CTR surgery on the affected hand.
• Patient has psychiatric history, head injury or any other condition which, in the Investigator's opinion, would prevent patient from complying with post-operative hand therapy or follow-up visits.