Transforaminal Lumbar Interbody Fusion (TLIF) IDE

Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One or Two Levels Using Infuse™ Bone Graft and The Capstone™ Spinal System with Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine.

I'm Interested

This research study is led by Dennis Oh, MD.

Contact: Jessica Vegerano, 413-794-3097

Participation Details:

Inclusion:

1. Has radiographic evidence (i.e. CT or MRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to root compression, manifested by:
   1. History of radiating le or buttock pain, paresthesia, numbness, or weakness, or
   2. History of neurogenic claudication.
2. Has a history of low back
3. Has preoperative Oswestry Disability Index score ≥ 35.
4. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.

Exclusion:

1. Prior surgical procedure at the involved or adjacent spinal levels (e.g. bony decompression, fusion, arthroplasty, and/or other non-fusion procedures).Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
2. Planned use of an internal or external bone growth stimulator.
3. Lumbar scoliosis > 30 degrees.
4. Morbidly obese, as defined by a Body Mass Index (BMI >40.
5. Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).