Clinical trial Recruiting at 1 site Interventional Ages 18 to 85

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 typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment100 (estimated)
SponsorQianfoshan Hospital
Academic / other
Locations1 site (Jinan, Shandong)
StatusRecruiting
StartedOctober 18, 2024
Main results expectedJuly 31, 2029
Study endsDecember 31, 2029
Registry record updatedOctober 21, 2024
Trial IDNCT06650046 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.