In This SectionTexas Health Research & Education Institute
Disease or Condition
Orthopedics / Spine
Use of FLEXICORE INTERVERTERBRAL DISC for spinal fusion surgery (Orthopedics / Spine)
The FlexiCore device is intended to replace a degenerated disc in mature patients.
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 on level (for the pivitol study) or two (adjacent) levels (for the ACR cohort) between L1 and S1, confirmed by:
a. Translational instability of equal to or greater than 3mm translation and/or
b. Angular instability of equal to or greater than 5 degree angulation, and/or
Decreased disc height by greater than 2mm 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 Oswesetry Low BAck Disability Questionaire score of at least 40%.
Subject has received non-operative treatment (change of activity and NSAIDS at a minimum) for back pain for a minimum of 6 months and is unresponsive.
Subject agrees to comply with this protocol, including participating in long-term follow up visits at the investigational site and completing study questionaires.
Subject can provide voluntary informed consent.
Subject reports a greater percentage of paon in either the right or left leg (radicular) alone compared with the percentage of back (axial) pain.
Subject clinically symptomatic DDD at more than one lumbar level (for the pivital study) or more than two lumbar levels, non-adjacent lumbar levels (for the ACR cohort).
Subject had any previous bilateral lumbar decompression, or unilateral decompression in which greater than 50 % of the ipsilateral facet has been removed, or a microdiscectomy (if facet fracture is suspected), or any lumbar fusion surgery (This is not intended to exclude IDET or closed laser discectomy).
Subject has clinically compromised vertebral body structure adjacent to any level(s) to be treated due to acute or past trauma, or signifigant ednplate incompetence adjacent to any level(s) to be treated such as Schmorl's node or vertebral endplate herniation.
Subject has signifigant motion segment instability at any level(s) to be treated adjacent level, defined as wither:
a. degenerative spodyloisthesis greater than 20% (Grade 1'); or
b. equal to or greater than 4mm translation (total excursion) on flexion/extension.
Subject has spodylolsis of lytic (isthmic) spondylolisthesis at any level(s) to be treated or an adjacent level.
Subject has moderate to severe spinal stenosis at any level(s) to be treated, or an adjacent level, rquiring posterior surgical decompression.
Subject has lumbar scoliosis of greater than 10 degrees.
MRI or CT myelography within the previous 6 months that confirmas signifigant facet hount arthritic changes at any level(s) to be treated or adjacent level
Subject has previously diagnosed Paget's disease, osteopenia (including osteroporosis or osteomalacia), or any other metabolic bone disease to a degree that spinal instruments would be contrindicated.
Subject is taking medications known to potentially interfer with bone/soft tissue healing, e.g. long temr use of cortosteriods (This is not intended to exclude inhalation medications for asthma).
Subject has am active infection - systemic or at the site of surgery.
Subject has been diagosed with reuhmatiod artritis, active hepatitis, AIDS, ARC or is HIV positive, or other medical conditions which could be expected to interfere with the patient's self-assesment of pain, function and qualityof life.
Subject has had a progressive neuromuscular disease or an active malignancy within the past 15 years, unless the malignancy was treated with curative intent and have been no clinical signs or symptoms for at least 5 years.
Subject has cervical myelopathy.
Subject is morbidly obebse, defined as a body mass index of greater than 40 or weight more than 100 lbs over ideal body weight.
Subject is pregnant or interested in becoming pregnant in the next 3 years (due to risk associated with x-ray exposure).
Subject has a know allergy to cobalt, chromium, molybdenum, titanium, or stainless steel.
Subject has had a surgical procedure involving general anesthesia or local/epidural anesthesua and an incision or any procedure that would increase risk of DVT within the last 30 days prior to the surgery planned by this protocol.
Subject is currently participationg in anothe investigational study for a similar purpose.
Subject has a mental illness or belongs to a vulnerable population (e.g., is a prisioner or a severe drug abuser, or is devlopmetally disabled) such that his or her ability to provide informed concsent or comply with the follow-up requirements is compromised.