Actively Recruiting
Study on Topping-off Technique for Treating LDD
Led by Qianfoshan Hospital · Updated on 2024-10-21
100
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Topping-off Technique for Treating LDD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical signs, physical examination, and imaging confirm degenerative lumbar spondylosis
- Underwent at least 3 months of conservative treatment without significant symptom relief
- Imaging shows disc 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 higher than 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
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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
CONTACT
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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