Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- neck pain
Overview
Brief Summary
- Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.
- Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.
- Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty.
Detailed Description
Surgery is performed under general anesthesia as before, followed by posterior cervical incision. In one group, the cervical spine of the C3 is removed using a drill and punch and C4-6 laminoplasty will be performed. In the other group, C3-6 laminoiplasty will be performed. Postoperative suturing and subject management are the same as existing patient care policies. Follow-up is performed at 1 month, 3 months, 6 months, 12 months, and 1 year after surgery at the outpatient clinic and x-ray is taken at each outpatient follow-up. The degree of the neck pain is measured using NDI and VAS for each outpatient f/u.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •cervical stenosis
Exclusion Criteria
- •metastatic tumor
- •previous cervical spine surgery (posterior approach)
Outcomes
Primary Outcomes
neck pain
Time Frame: 1 year
Numerical rating pain score on neck, 0\~10, 0 is no pain, 10 is maximum pain
Secondary Outcomes
No secondary outcomes reported
Investigators
Chun Kee Chung
professor
Seoul National University Hospital