New technique for treating lumbar degenerative disease
Study on Topping-off Technique for Treating Lumbar Degenerative Diseases
This study is testing a new surgery called the Topping-off technique to see if it can help people with certain back problems feel less pain and keep some movement in their lower spine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06650046 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Topping-off technique, a novel approach for treating lumbar degenerative disease, which combines posterior lumbar interbody fusion and dynamic fixation. The aim is to reduce pressure on the intervertebral disc while preserving some mobility in the lumbar spine. Patients with specific degenerative conditions at the L4-5 and L5-S1 segments will undergo this two-stage surgical procedure, with follow-up assessments conducted over an average of 24 months. Clinical efficacy will be measured using various pain and function scales, alongside imaging studies to monitor changes in the lumbar spine.
Who should consider this trial
Good fit: Ideal candidates are middle-aged or elderly patients with degenerative lumbar spondylosis who have not improved after conservative treatment.
Not a fit: Patients with severe osteoporosis, significant lumbar instability, or systemic diseases affecting surgical outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide a safer and more effective treatment option for patients suffering from lumbar degenerative disease.
How similar studies have performed: While traditional surgical methods have been successful, the Topping-off technique is a novel approach that has not been widely tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient's clinical manifestations, physical examination, and imaging data all support the diagnosis of degenerative lumbar spondylosis. * Those who have undergone strict and formal conservative treatment for at least 3 months before surgery and have no significant improvement in symptoms. * Preoperative imaging examination showed L4-5 and L5-S1 responsible segment protrusion or protrusion leading to segment stenosis. * Surgeries are performed by the same chief surgeon. Exclusion Criteria: * Lumbar instability, lumbar spondylolisthesis above grade II. * Patients with severe osteoporosis, tuberculosis, or tumors. * Systemic diseases that affect surgical treatment and medication, such as heart disease, liver disease, and kidney disease. * Patients with mental illness, poor compliance, and inability to cooperate in completing follow-up.
Where this trial is running
Jinan, Shandong
- The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Hao-Xuan Zhang, Ph.D/MD
- Email: hoho0605@126.com
- Phone: CN+86+15275105665
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.