The purpose of this study is to compare the healing of the patients spine at 24-months following surgery and screw placement among 3 groups. The doctor will also compare clinical outcomes and the immediate and delayed medical and surgical complications among the 3 study groups. The goal of this study is to determine if treating patients with one of the 3 groups is better than the others.
Patient must be between 18 and 80 years old and have problems with the bones in there lower back (lumbar disease) for which Cautious management over at least 3 months has not brought relief from back and/or leg pain. Patients will be scheduled to undergo surgery to treat there lumbar disease. The surgery will be followed by placement of screws in the back of the bones of there lower back. This includes placing solid metal rods that are connected and secured to adjacent vertebrae (bones of the back) using screws. The screws are used to hold the spine together. Everyone who takes part in this study will be assigned to one of the following 3 study groups: 1) One-sided screw placement into the bones above and below the area where the nerve is being surgically relieved of its pinching; 2) Same as group 1 but with an additional stand alone screw which crosses the spinal joint placed into the joint on the other side; 3) Screw placement on both sides into the bones above and below the area where the nerve is being surgically relieved of its pinching.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
The Ohio State Unviersity
Columbus, Ohio, United States
Compare Bony Fusion Rates Radiographically Using CT Scans
Primary Outcome: To compare bony fusion rates at two years among the three study arms, using the Brantigan, Steffee and Fraser scale. Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspace.
Time frame: 24 months
Bony Fusion Rates Compared Clinically Using the Visual Analog Scale (VAS) Survey
To compare clinical outcomes among the three study arms utilizing the Visual Analog Scale (VAS) survey. Visual analog scales will be used to assess neck, back, arm, and leg pain. Scores can range from 0 - 10 with higher scores indicating higher levels of pain.
Time frame: 3 months, 6 months, 12 months, 24 months
Bony Fusion Rates Compared Clinically Using the Oswestry Disability Index v2 (ODI v2) Survey
To compare clinical outcomes among the three study arms utilizing the Oswestry Disability Idex (ODI) survey. This survey will be used to assess how back pain affects patients' ability to function in everyday life. Scores can range from 0% to 100% with higher scores indicating higher levels of disturbance in everyday life.
Time frame: 3 months, 6 months, 12 months, 24 months
Bony Fusion Rates Compared Clinically Using the Short Form 36 Health Survey v2 (SF-36 v2)
To compare clinical outcomes among the three study arms utilizing the Short Form 36 Health Survey (SF-36). This survey will be used to assess patients' physical and mental health. Scores range from 0 to 100 with higher scores indicating better physical and mental health.
Time frame: 3 months, 6 months, 12 months, 24 months
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