The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.
There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine
Removal of bone to decompress spinal nerves
Greenwich Hospital
Greenwich, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
Cleveland Clinic Spine Institute
Cleveland, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
SF-36 (physical component summary score)
Time frame: 2 year
Oswestry Disability Index
Time frame: 2 year, 3 year, 4 year
Major Complication rate
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.