Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty. There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1\~3 year
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
C3 laminectomy preserving semispinalis cervicis inserted into the axis.
Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
Seoul National University Hospital
Seoul, Korea, South Korea
C2-C7 Lordosis
Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
the Neck Disability Index (NDI)
scores from 0 to 50 with 50 being the worst performance status related to neck pain.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C2-C3 Lordosis
Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C4-C7 Lordosis
Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Cervical Sagittal Vertical Axis (cSVA)
Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope
Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
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Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope Minus Cervical Lordosis
Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C2-C3 Interlaminar Spontaneous Fusion
Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.
Time frame: at 2 year
EuroQol Five-dimensional Questionnaire (EQ-5D) Scores
Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO).
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Posterior Neck With Numering Rating Scale (NRS-N)
Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Upper Limb Pain With Numering Rating Scale (NRS-L)
Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Estimated Intraoperative Blood Loss
Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.
Time frame: Intraoperative
Operative Time
Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).
Time frame: Intraoperative