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  • Balloon Carpal Tunnel-Plasty Study

    To National and International Hand Surgeons:

    New treatment for Carpal Tunnel Syndrome
    Balloon Carpal Tunnel-Plasty

    Dear Colleague:

    We are conducting a FDA approved clinical study of a new surgical
    procedure for the treatment of carpal tunnel syndrome.

    It is called Balloon Carpal Tunnel-Plasty and, like the angioplasty of
    heart procedures, this new method relies on a balloon to stretch rather
    than cut the transverse carpal ligament.
    The principle is that by stretching the ligament, the size of the tunnel
    is increased and stretching the ligament decreases pressure on the
    median nerve. There is no cutting in the carpal tunnel.

    The new technique, Balloon Carpal Tunnel-Plasty, requires specialized
    equipment designed for this procedure.
    It involves the use of a balloon catheter device, which is built into a
    specialized nerve protector to stretch and expand the transverse carpal
    ligament relieving the symptoms of carpal tunnel syndrome.

    The procedure is performed through a one-centimeter size incision at the
    distal palmar crease ulnar to the palmaris longus in
    line with the fourth ray. The approach is identical to the single portal
    endoscopic technique.

    Balloon Carpal Tunnel-Plasty avoids transection of the transverse carpal
    ligament, which we feel serves a protective purpose in the hand. We
    believe that by not cutting the ligament there will be less alteration
    of the biomechanics of the hand. The procedure should decrease the
    incidence of scar formation and perineural fibrous in the carpal tunnel
    that is common after open or endoscopic carpal tunnel release procedures
    that cut the ligament.The patient should have a very rapid recovery
    period with early return to activities of daily living. We feel that
    this procedure is less invasive, safer, more physiologic and has an
    easier learning curve for the surgical treatment of carpal tunnel
    syndrome than can be obtained with other
    methods.

    Balloon Carpal Tunnel-Plasty was developed in the laboratory with
    anatomical and biomechanical study. Our investigative group has
    successfully performed it over the past five years in over 200 patients
    with excellent results.

    To be eligible for this study, a patient must be between the ages of 20
    to 75 years of age with a positive history of symptoms consistent with
    carpal tunnel syndrome of over three months duration. A detailed medical
    history is requested which includes a list of any previous medical
    illness, previous surgery, medications, allergies and history of any
    family illness. A description of the patient's occupation as well as any
    precipitating factors that may have exacerbated the patient's condition.
    A complete physical examination must be performed documenting positive
    clinical findings consistent with the diagnosis of carpal tunnel
    syndrome. Recent, within 4 months, positive electrodiagnostic studies
    are required, which confirm
    median nerve compression at the level of the carpal tunnel.
    All patients must sign a fully informed surgical consent to paticipate
    in the study which is double blinded comparing Balloon Carpal
    Tunnel-Plasty to open carpal tunnel release.

    The FDA has reviewed the procedure and given approval for a national
    clinical trial.

    The study protocol is available at your request.

    The study is sponsored by Surgical Dynamics, a division of the United
    States Surgical Corporation.

    Participating centers:

    Orthopaedic Associates, Fair Lawn, New Jersey
    The Philadelphia Hand Center, Philadelphia, Pennsylvania
    Loyola University Medical Center, Chicago, Illinois
    Western Medical, Logan, Utah
    Westchester Bone and Joint Associates, North White Plains, New York

    If you have a patient that you feel would benefit from the Balloon
    Carpal Tunnel-Plasty procedure, please e-mail us at:
    Carpaltunnel@hotmail.com

    If you would be interested in more information or joining us as an
    investigator, please e-mail us at: Carpaltunnel@hotmail.com

    Sincerely,
    Lee Berger
    Orthopaedic Associates
    1501 Broadway, Suite 20
    Fair Lawn, New Jersey 07410
    201-794-6008

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