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.
This research study is led by Dennis Oh, MD.
Contact: Jessica Vegerano, 413-794-3097
August 27, 2021
Baystate Medical Center
The purpose of this study is to evaluate the safety and effectiveness of the Investigational treatment as compared to the control and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
- 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:
- History of radiating le or buttock pain, paresthesia, numbness, or weakness, or
- History of neurogenic claudication.
- Has a history of low back
- Has preoperative Oswestry Disability Index score ≥ 35.
- 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.
- 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.
- Planned use of an internal or external bone growth stimulator.
- Lumbar scoliosis > 30 degrees.
- Morbidly obese, as defined by a Body Mass Index (BMI >40.
- 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).
Expected to be 60 months.