Artimplant (STO:ARTIB) is taking its first step towards treatment of spinal disorders with its proprietary biomaterial Artelon(R). An Artelon(R) implant will now be used for investigational treatment of osteoarthritis of the lumbar facet joints. The investigator, Schulthess Clinic Spine Center, plans to start enrolling patients during the second quarter of 2009.
Schulthess Clinic Spine Center in Zurich has received the letter of confirmation from Swissmedic to commence the clinical investigation of an Artelon(R) implant. The aim of this pilot clinical investigation is to evaluate the feasibility of treating painful osteoarthritis of the lumbar facet joints of the spine with an Artelon(R) implant. The pain relief provided by this treatment will be examined and the patients will be followed up for two years. The study will form the basis for documenting the safety and ease of use of the Artelon(R) implant in spine applications and establishing the post-surgical instructions.
Artimplant has more than nine years’ clinical experience of Artelon(R) in the treatment of osteoarthritis in small joints in the hand, wrist and foot. The principles behind helping the body to heal and regain functional joints do not differ to any great extent from one part of the body to another. Applying the Artelon(R) resurfacing concept to the facet joint is a logical step for Artimplant and is in line with the trend in spine surgery towards motion preservation. Compared to other spine surgery alternatives the procedure is simple. Implanting the Artelon(R) device is less invasive than most other spine procedures and can be performed through the patient’s back. Thereby the patient can resume normal activities after a short recovery period.