The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine
Not Applicable
Completed
- Conditions
- Cervical VertebraeSingleDegenerative Disease
- Interventions
- Procedure: Plate fusionProcedure: Cage fusion
- Registration Number
- NCT02030899
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.
- Detailed Description
cage: MC+® cage plate: atlantis® plate
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Single level degenerative cervical spine disease
- aged 30 - 70
- no improvement of symptom for 8 weeks of non-surgical treatment.
- degeneration in other levels without stenosis, accepted
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Exclusion Criteria
- osteoporosis
- disease with poor bone quality
- Cancer
- Previous cervical spine surgery
- Multiple levels disease
- Ossification of posterior longitudinal ligament
- Kyphosis at the index level
- Developmental stenosis (diameter of C7 spinal canal < 10mm)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Plate Plate fusion Plate augmentation after iliac bone graft Cage Cage fusion Cage filled with autologous bone
- Primary Outcome Measures
Name Time Method Fusion rate 2 years The rate of interbody fusion at 2 years
- Secondary Outcome Measures
Name Time Method cervical lordosis 2 years The cervical lordosis at 2 years
Segmental angle 2 years the segmental angle at the fused level
pain change 2 years Visual analogue pain score
functional status change. 2 years Neck disability index
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of