Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then utilizes a spinal fixation system to stabilize the structure to relieve lower limb pain, paralysis, and other symptoms. However, the spinal cord that lacks lamina coverage after surgery is often compressed by scar tissue formation and hematoma, leading to postoperative back and lower limb pain. Therefore, this trial is divided into two groups, comparing the use of the cross connector of the ORION spinal system - the spinal lamina cover and the general spinal fixation system (without lamina cover). For participants undergoing laminectomy with internal fixation and osseofusion, after utilizing the spinal lamina cover of the ORION spinal system, whether the nerve compression caused by postoperative scar tissue formation and hematoma can be effectively reduced, and the pain in the back and lower limbs can be improved.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Sham
an artificial lamina coverage of the ORION spinal system
Taipei Veterans General Hospital
Taipei, Taiwan
Magnetic Resonance Imaging (MRI)
To observe the recovery of the participants' spine
Time frame: Six months after surgery
Visual Analogue Scale (VAS)
To measure the pain and numb of the participants' back and limbs
Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Oswestry Disability Index (ODI)
To evaluate the functional disability of the participants' limbs
Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Sort Form-12 Health Survey (SF-12)
To evaluate the physical health of the participants
Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
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