In This SectionTexas Health Research & Education Institute
Disease or Condition
Orthopedics / Spine
Treatment of degenaratice disc disease in the lumbosacral spine (Orthopedics / Spine)
Trial to evaluate the safety and effectiveness of the Prodisc in the treatment of discogenic pain associated with one or two levels of degenarative disc disease in the lumbosacral spine.
Degenerative disc disease (DDD) in one or two adjavent vertebral levels between L3 and S1.
Diagnosis of DDD requires
a. Back and or leg (radicular) pain; and
b. Radiographic conformation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexation/ extension films:
i. Instability (greater than 3mm translation or 5 degrees of angualtion).
ii. Decreased disc height of greater than 2mm.
iii. Scarring/ thickening of annulus fibrosis.
iv. Herniated nucleus pulposus; or
v. Vacuum phenomenon.
Age between 18 and 60 years.
Failed at least 6 months of conservative treatment.
Oswestry low back pain disability questionaire score of at least 20/50 (40%) (interpreted as moderate/sever disability).
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Signed consent form.
No more than 2 vertebral levels may have DDD and all diseased levels, wither one or two, must be treated.
Patients with involved vertebral endplates dimensionally amsller than 34.5 mm in the medial-lateral and/or 27mm in the anterior-posterior directions.
KNow allergy to titanium, polyethylene, cobalt, chromium or molybdenum.
Prior fusion surgery at any vertebral level.
Clinically compromised vertebral bodies at the affected level(s) du to current trauma.