Actively Recruiting
Study on Topping-off Technique for Treating Lumbar Degenerative Diseases
Led by Qianfoshan Hospital · Updated on 2024-10-21
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lumbar degenerative disease commonly affects middle-aged and elderly individuals and those who sit for prolonged periods, causing lower back pain, stiffness, and numbness in the legs. Researchers are evaluating the Topping off technique, a new treatment combining interbody fusion and dynamic fixation, to see if it can reduce pressure on affected discs, promote repair, and preserve some lumbar spine movement. This study compares the Topping off method with traditional two-stage fusion surgery in patients with degenerative lumbar diseases at the L4-5 and L5-S1 spinal segments. The study involves two groups: one receiving the Topping off technique, which includes posterior lumbar interbody fusion (PLIF) combined with Wallis interspinous dynamic fixation device implantation, and the other treated with standard lumbar fusion surgery. Both groups consist of patients who underwent surgery for continuous double segment lumbar degenerative diseases. Follow-up occurs before and after surgery, with an average period of 24 months, to assess treatment effects. Participants will be evaluated using the Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS), and Japanese Orthopaedic Association (JOA) lumbar spine function score to measure clinical outcomes. Imaging tests like X-rays and MRIs will assess lumbar range of motion, device segment mobility, intervertebral disc height, and nucleus pulposus signal intensity. The primary outcomes include pain, function scores, and spinal alignment angles measured over two years. The study is randomized and quadruple-blinded, led by Qianfoshan Hospital.
CONDITIONS
Brief Title
Study on Topping-off Technique for Treating LDD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of degenerative lumbar spondylosis confirmed by clinical, physical, and imaging findings
- Underwent at least 3 months of formal conservative treatment without significant symptom improvement
- Imaging shows protrusion or stenosis at L4-5 and L5-S1 segments
- Surgery performed by the same chief surgeon
You will not qualify if you...
- Lumbar instability or spondylolisthesis above grade II
- Severe osteoporosis, tuberculosis, or tumors
- Systemic diseases affecting surgery or medication, such as heart, liver, or kidney disease
- Mental illness, poor compliance, or inability to complete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo either the Topping-off technique surgery or lumbar spine fusion surgery for lumbar degenerative diseases.
1 surgical procedure with hospital stay
Duration - Up to 24 months
Participants are followed for clinical efficacy and imaging changes, including assessments of pain, lumbar function, spinal motion, and imaging studies.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
H
Hao-Xuan Zhang, Ph.D/MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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