N/A
N=122
Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Myelopathy Cervical · Kyphosis Post Surgical · Neck Pain · Ossification of Posterior Longitudinal Ligament · Cervical Spondylosis With Myelopathy
Bottom Line
View on ClinicalTrials.gov: NCT05006495 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: C2-C7 Lordosis — 11.0; 10.9 °
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- C3 laminectomy (Procedure); C3 laminoplasty (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C2-C7 Lordosis |
11.0; 10.9 | — |
| PRIMARY the Neck Disability Index (NDI) |
12.8; 8.6 | — |
| SECONDARY C2-C3 Lordosis |
7.1; 3.2 | — |
| SECONDARY C4-C7 Lordosis |
3.9; 7.7 | — |
| SECONDARY Cervical Sagittal Vertical Axis (cSVA) |
31.6; 25.5 | — |
| SECONDARY T1 Slope |
25.8; 25.3 | — |
| SECONDARY T1 Slope Minus Cervical Lordosis |
15.0; 14.9 | — |
| SECONDARY C2-C3 Interlaminar Spontaneous Fusion |
5; 26 | — |
| SECONDARY EuroQol Five-dimensional Questionnaire (EQ-5D) Scores |
0.661; 0.743 | — |
| SECONDARY Posterior Neck With Numering Rating Scale (NRS-N) |
2.8; 2.0 | — |
| SECONDARY Upper Limb Pain With Numering Rating Scale (NRS-L) |
3.7; 2.8 | — |
| SECONDARY Estimated Intraoperative Blood Loss |
169; 182 | — |
| SECONDARY Operative Time |
126; 118 | — |
Summary
Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
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
Data sourced from ClinicalTrials.gov (NCT05006495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.