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Keyhole Lumbar Intervertebral Disc Nucleus Replacement Clinical Study

The Spinal Foundation is conducting a safety study for keyhole lumbar intervertebral disc nucleus replacement.

Patients suffering from chronic back pain have traditionally been advised to learn to cope with it, or undergo major spinal reconstruction such as spinal fusion or total disc replacement. There have not been many treatment choices for physicians to offer patients who have failed intensive and prolonged physiotherapy, pain medication and other non-operative measures.

The Spinal Foundation study is looking for patients suffering from chronic back pain, age between 18 and 60 years and that meet the following inclusion criteria:

1)    Degenerative disc disease between lumbar 1 and sacrum as diagnosed by the following:

        a)    Back and/or leg pain
        b)    Confirmation of herniated nucleus pulposus (contained, partial and/or complete) by CT, MRI, discography, plain film, myelography and/or flexion/extension films.

2)    Patient deemed a good candidate for one level or two level total disc replacement or a spinal reconstruction.

3)    Psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow up schedules and requirements and the filling out of forms.

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