Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650046
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Study on Topping-off Technique for Treating LDD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on Topping-off Technique for Treating Lumbar Degenerative Diseases
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 spineThe 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 L2S1ROM 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
Detailed Description:
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 L2S1ROM 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None