New technique for treating lumbar degenerative disease
Official title: Study on Topping-off Technique for Treating Lumbar Degenerative Diseases
Run by Qianfoshan Hospital · NCT06650046 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | October 18, 2024 |
| Main results expected | July 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | October 21, 2024 |
| Trial ID | NCT06650046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are middle-aged or elderly patients with degenerative lumbar spondylosis who have not improved after conservative treatment.
✕Probably not a fit
Patients with severe osteoporosis, significant lumbar instability, or systemic diseases affecting surgical outcomes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While traditional surgical methods have been successful, the Topping-off technique is a novel approach that has not been widely tested in previous studies.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Spine Surgery
This study tests whether the height of the irrigation fluid bag and the direction of the surgical cut affect fluid pressure, visibility, and early recovery in adults undergoing unilateral biportal endoscopic spine surgery.
-
Pre-surgery preparation program for older adults having lumbar fusion
This trial will try a 6-week multimodal prehabilitation program to help people aged 75 and older having elective lumbar fusion recover independence and reduce complications after surgery.
-
Comparing mini‑TLIF versus MIDLIF for disc-related low back pain
This trial tests whether mini‑TLIF or MIDLIF gives better pain relief, fewer complications, and lower costs for adults with discogenic lower back pain who haven't improved with non-surgical treatment.
-
Evaluation of a new device for spinal fusion in patients with lumbar degeneration
This study is testing a new 3D printed titanium device for spinal fusion in patients with lower back problems to see how well it works compared to older options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.