NCT06650046 Study on Topping-off Technique for Treating LDD
| NCT ID | NCT06650046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qianfoshan Hospital |
| Condition | Lumbar Degenerative Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-10-18 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lumbar degenerative disease is a common disease among middle-aged and elderly people as well as those who sit for a long time, mainly manifested as symptoms such as lower back pain, stiffness, and numbness in the lower limbs. Traditional surgical treatments such as lumbar fusion can alleviate symptoms, but may lead to complications such as adjacent segment degeneration. Therefore, exploring safer and more effective treatment methods is of great significance. Topping off technique, as a new treatment method, combines the advantages of interbody fusion and dynamic fixation, aiming to reduce the pressure on the intervertebral disc at the surgical site, promote the repair of diseased intervertebral discs, while preserving partial mobility of the lumbar spine.The aim of this study is to evaluate the clinical efficacy and imaging changes of Topping off technique in the treatment of lumbar degenerative diseases. The Topping off technique combines posterior lumbar interbody fusion (PLIF) and Wallis interspinous dynamic fixation device implantation. Through prospective clinical trials, its therapeutic effect on patients with continuous double segment lumbar degenerative diseases was observed. The study included patients who underwent surgery for degenerative lumbar diseases in L4-5 and L5-S1, who were treated with two-stage fusion surgery and Topping off technique, respectively. Follow up was conducted before and after surgery, with an average follow-up time of 24 months. Evaluate preoperative and postoperative efficacy using Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS), and Japanese Orthopaedic Association (JOA) lumbar spine function score, and calculate recovery rate. At the same time, X-ray and MRI images were used to detect the overall range of motion (L2\~S1ROM) of the lumbar spine, the range of motion (ROM) of the Wallis device inserted segments, the intervertebral disc height index (DHI), and the relative signal intensity of the nucleus pulposus (RSI) of the intervertebral disc.
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.
Contact & Investigator
Hao-Xuan Zhang, Ph.D/MD
STUDY CHAIR
Shandong First Medical University
Frequently Asked Questions
Who can join the NCT06650046 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Lumbar Degenerative Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06650046 currently recruiting?
Yes, NCT06650046 is actively recruiting participants. Contact the research team at hoho0605@126.com for enrollment information.
Where is the NCT06650046 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06650046 clinical trial?
NCT06650046 is sponsored by Qianfoshan Hospital. The principal investigator is Hao-Xuan Zhang, Ph.D/MD at Shandong First Medical University. The trial plans to enroll 100 participants.