An interventional study of extended one-level interbody fusion in Adjacent Segment Degeneration, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
The main objective of this study was to validate the clinical effectiveness of interbody fusion with a one-segment extension for the treatment of adjacent segmental space discs in the surgical treatment of lumbar degeneration.
The study will include patients with lumbar degeneration who underwent 1-2 segment interbody fusion, and for patients with vacuum signs but no symptoms and no instability of the discs in the adjacent segments of the operated segments, lumbar interbody fusion will be extended by one segment, and the patients will be followed up annually in the immediate postoperative period, in March, June, and in the period of 1-5 years, and lumbar MR will be taken at the time of follow-up to determine the degree of progression of the degeneration in the neighboring segments, and whether or not revision surgery is needed. The lumbar spine was photographed in the frontal and lateral + anterior flexion and posterior extension X-rays and CT-3D reconstruction to determine the bony fusion of the interbody fusion. In addition, the lumbar spine ODI score was applied for evaluation at the follow-up visit, and the total lumbar spine-related expenses of the patients up to the follow-up visit were recorded.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's planned enrollment of 126 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
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Exclusion Criteria:
The study will enroll patients with lumbar degeneration undergoing 1-2 level intervertebral fusion, and for patients with asymptomatic and non-instability intervertebral discs adjacent to the operative level with vacuum signs, extended one-level interbody fusion will be performed.
Procedure: extended one-level interbody fusion
The control group underwent intervertebral fusion only at the responsible segment.
For patients who have vacuum signs in the intervertebral disc adjacent to the surgical segment but are asymptomatic and not unstable, the intervertebral fusion surgery is extended to one segment and followed up immediately after surgery, 3 months, 6 months, and annually within 1 to 5 years. Take lumbar spine MR to determine the degree of degeneration progression of adjacent segments and whether revision surgery is needed. Take X-rays of the lumbar spine in frontal and lateral + flexion and extension positions, and CT-three-dimensional reconstruction to judge the bony fusion of the intervertebral fusion.
Surgical revision rate
MR of the lumbar spine was taken at follow-up to determine the degree of progression of degeneration in the neighboring segments and the need for revision surgery.
Time frame: Postoperative month 3 (±15 days), month 6 (±15 days), yearly for 5 years (±30 days)
Plan to share: No
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Intervertebral Disc Degeneration→
Xuanwu Hospital, Beijing