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Search / Trial NCT06650046

Study on Topping-off Technique for Treating LDD

Launched by QIANFOSHAN HOSPITAL · Oct 17, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Topping Off Technique

ClinConnect Summary

This clinical trial is studying a new treatment method called the "Topping off technique" for people suffering from lumbar degenerative disease, which often causes lower back pain, stiffness, and numbness in the legs. The goal of this trial is to see if this technique, which combines two different surgical approaches, can improve patients' symptoms while preserving some movement in the spine, compared to traditional surgery. The study will involve patients who have already tried other treatments for their back pain without success and have specific issues in their lower back that need to be addressed through surgery.

To participate, individuals must be between the ages of 65 and 74, have symptoms that match the diagnosis of degenerative lumbar disease, and have not responded well to at least three months of conservative treatment (like physical therapy). Participants will undergo surgery and then be followed for about two years to evaluate their recovery and improvements in their back function and pain levels. It's important to note that people with certain conditions, like severe osteoporosis or significant mental health issues, will not be eligible for this trial. If you or a family member are considering participating, you can expect close monitoring and a focus on improving your back health.

Gender

ALL

Eligibility 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.

About Qianfoshan Hospital

Qianfoshan Hospital is a leading medical institution dedicated to advancing healthcare through innovative clinical research and trials. Located in Shandong Province, China, the hospital is renowned for its commitment to excellence in patient care and medical education. With a multidisciplinary team of experienced professionals, Qianfoshan Hospital focuses on a wide range of therapeutic areas, striving to enhance treatment options and improve patient outcomes. The institution actively collaborates with various stakeholders to ensure the highest standards of ethics and efficacy in its clinical research endeavors.

Locations

Jinan, Shandong, China

Patients applied

0 patients applied

Trial Officials

Hao-Xuan Zhang, Ph.D/MD

Study Chair

Shandong First Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported