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A prospective randomized trial comparing cementing the apical and terminal pedicle screw and cement injections on all segments for lumbar degenerative diseases

Phase 1
Conditions
lumbar degenerative diseases
Registration Number
ITMCTR1900002509
Lead Sponsor
Spinal Surgery, the First Affiliated Hospital of Guangzhou University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. diagnosed with lumbar degenerative diseases, including lumbar spondylolisthesis, lumbar spinal stenosis, degenerative scoliosis, spinal instability;
2. patients suffered from severe low back pain and/or lower limb pain before operation and were ineffective after regular conservative treatment for more than three months.
3. patients with lumbar vertebral bone mineral density (BMD) measured by dual-energy X-ray absorptiometry and T <= -2.5 SD.
4. patients with posterior interbody fusion and using consecutive 2-level (fusion segment:L2-L4, L3-L5 or L4-S1) or 3-level (fusion segment: L2-L5 or L3-S1) pedicle screw implanting.

Exclusion Criteria

1. patients with vertebral fracture, tumor or infection;
2. patients with lumbar surgery history;
3. allergy to bone cement ;
4. serious medical diseases or intolerance to operation.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
fusion rate;screw loosening rate;cement leakage rate;
Secondary Outcome Measures
NameTimeMethod
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