Analyzing mechanical complications in degenerative lumbar scoliosis surgery
Clinical Study of Imaging and Endoplant-related Mechanical Complications After Long Segment Fixation and Fusion of Degenerative Lumbar Scoliosis (DLS)
This study looks at patients with degenerative lumbar scoliosis who had surgery to see how often they experience complications and what might cause them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04960423 on ClinicalTrials.gov |
What this trial studies
This observational study aims to retrospectively analyze patients with degenerative lumbar scoliosis who underwent long segment fixation and fusion surgery. It focuses on collecting and examining patients' basic data, surgical details, and imaging data from preoperative, immediate postoperative, and follow-up periods. The study seeks to identify the incidence of distal mechanical complications and their risk factors, as well as their relationship with clinical symptom scores. The findings are intended to guide clinical decision-making for surgical operations.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45 and older with degenerative lumbar scoliosis who have undergone long segment fixation and fusion surgery.
Not a fit: Patients with idiopathic scoliosis, neuromuscular scoliosis, or a history of spinal surgery or trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce complications for patients undergoing surgery for degenerative lumbar scoliosis.
How similar studies have performed: While there is limited research specifically on this topic, similar studies on mechanical complications in spinal surgeries have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥45 years old; * The number of fixed vertebral bodies ≥5, and the upper instrumented vertebra (UIV) is located in the thoracolumbar segment; * Third generation total pedicle screw internal fixation system; * Follow-up time ≥24 months; * Complete clinical and imaging data. Exclusion Criteria: * Idiopathic scoliosis, neuromuscular scoliosis, non-structural scoliosis, spinal tumors, spinal tuberculosis, ankylosing spondylitis, humman's disease, history of spinal surgery, history of spinal trauma, and history of hip surgery
Where this trial is running
Beijing, Beijing
- Peking University of Third Hospital — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.