Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myelopathy Cervical
- Sponsor
- Seoul National University Hospital
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- C2-C7 Lordosis
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
Detailed Description
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
Investigators
Chun Kee Chung
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Cervical stenosis patients with or without cervical myelopathy.
Exclusion Criteria
- •Metastatic cancer patients.
- •Any combined fracture.
- •Previous surgery to cervical spine.
- •inflammatory joint disease
- •psychiatric illness
Outcomes
Primary Outcomes
C2-C7 Lordosis
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
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.
the Neck Disability Index (NDI)
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
scores from 0 to 50 with 50 being the worst performance status related to neck pain.
Secondary Outcomes
- C2-C3 Interlaminar Spontaneous Fusion(at 2 year)
- T1 Slope Minus Cervical Lordosis(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- EuroQol Five-dimensional Questionnaire (EQ-5D) Scores(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- T1 Slope(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- C2-C3 Lordosis(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- C4-C7 Lordosis(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Cervical Sagittal Vertical Axis (cSVA)(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Operative Time(Intraoperative)
- Posterior Neck With Numering Rating Scale (NRS-N)(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Upper Limb Pain With Numering Rating Scale (NRS-L)(at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements))
- Estimated Intraoperative Blood Loss(Intraoperative)