Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Location status: Recruiting
Location contact
Fengzeng jian, MD,PhD
CONTACT
Hao Wu, MD,PhD
CONTACT
NCT Number: NCT06029764
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, China
Location status: Recruiting
Fengzeng jian, MD,PhD
CONTACT
Hao Wu, MD,PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Postoperative month 3 (±15 days), month 6 (±15 days), yearly for 5 years (±30 days)
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.
Contact information is provided by the study sponsor or research team.
Fengzeng Jian, MD,PhD
CONTACT
Hao Wu, MD,PhD
CONTACT
Xuanwu Hospital, Beijing
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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