Study on Topping-off Technique for Treating Lumbar Degenerative Diseases

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Shandong First Medical University
RECRUITING
Jinan
Contact Information
Primary
Hao-Xuan Zhang, Ph.D/MD
hoho0605@126.com
CN+86+15275105665
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Topping-off group
Topping-off group Patients who have undergone the Topping-off surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University.
Active_comparator: Fusion group
Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University.
Sponsors
Leads: Qianfoshan Hospital

This content was sourced from clinicaltrials.gov