In This SectionTexas Health Research & Education Institute
Disease or Condition
Orthopedics / Spine
Use of FLEXICORE INTERVERTERBRAL DISC for spinal fusion surgery (Orthopedics / Spine)
To compare the safety and effectiveness of the Flexicore Intervertebral Disc to spinal fusion surgery for the treatment of discogenic pain unresponsive to conservative treatment with degenerative disc disease at a single level in the lumbar spine.
Subject is skeletally mature and between 18 and 60 years of age, inclusively.
Subject has DDD (back pain of discogenic origin with degeneration of the disc) at single level between L1 and S1, confirmed by:
a. Subject reports a greater percentage of back (axial) pain compared with the percentage of pain in either the left or the right leg (radicular) alone; and
b. CT, MRI myelography, or lateral felxion/extension films demonstrating:
i. Translation instability (equal to or greater than 3mm translation) and/or
ii. Angular instability (equal to or greater than 5 degee anulation), and/or
iii. Decreased disc height (decreased by greater than 2mm and compared to adjacent (cranial) disc height).
Subject records a pre-operative VAS score for back pain of at least 40 on a 0-100 point scale.
Subject records a pre-operative Owsestry Low Back Questionaire score of at least 40/100 (40%).
Subject has received conservative (non-surgial) treatment for back pain for a minimum of 6 months and is unresponsive.
Subject agrees to comply with the protocol, including participating in long-term follow up visits at the investigational site and completing study questionaires.
Subject can provide voluntary informed concent.
Subject reports a greater percentage of pain in either the right or left leg (radicular) alone and compared with the percentage of back (axial) pain.
Subject has symptomatic DDD at more than on lumbar level.
Subject previously had: an open l umbar decompressive procedure, a microdiscectomy (if facet fracture is suspected), or any lumber fusion surgery. (IDET or closed laser discectomy alone are not, in and of themselves, are not grounds for exclusion.)
Subject has clinically comprised vertebral body structure at the affected level due to acute or past trauma, or signifigant endplate incompetence such as Schmorl's node or vertebral disc herniation.
Subject has signifigant motion segment instability at the level to be treated or an adjacent level, defined as either:
a. degenerative spondyloisthesis greater than 20% (Grade 1'); or
b. Equal to or greater than 4mm tranlation (total excursion) or fleion/extension.
Subject has spondylolysis or lytic (isthmic) spondyloithesis at the level to be treated or adjacent level.
Subject jas moderate to severe spinal stenosis at the level to be treated, or or an adjacent level, requiring surgiacal decompression.
Subject has lumbar scloliosis greater than 10 degrees.
MRI or CT confirmation of signifigant facet joint arthritic changes at the level to be treated or adjacent level.
Subject has perviously diagnosed osteoporosis, Paget's disease, osteomalacia, or any other metabolic bone disease to a degree that spinal instrumentation would be contraindicated.
Subject is taking medications known to potentially interfere with bone/soft tissue healing, e.g., long term use of corticosteriods ( this does not exclude inhaltion medicationd for asthma).
Subject has an activce infection - systemic or at the site of intended surgery.
Subject has been diagnosed with rheumatiod arthritis, autoimmune disease, hepatitis, AIDS, or ARC, or is HIV positive.
Subject has had a progressive neuromuscular disease or an active malignancy within the last 15 years, unless the malignancy was treated with curative intent and there have been no cliniical signs or symptoms for at least 5 years.
Subject has cervical myelopathy.
Subject is morbidly obese, defined as a body mass index of greater than 40 or a weight more than 100 lbs over ideal body weight.
Subject is pregnant or interested in becoming pregnant in the next 3 years.
Subject has a known allergry to cobalt, chromium, molybdenum, titanium, or stainless steel.
Subject has had other surgical procedures within the last 30 days.
Subject is currently participating in another investigational study for a simialr purpose.
Subject has a mental illness or belongs to a vulnerble population (e.g., is a prisoner or a severe drug abuser, or is devlopmentally disabled) such as his or her ability to provide informed consent or comply with follow up requirements is compromised.