NCT06029764|Recruiting
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Sponsor study identifier
interventional
126
1 country
1
Study Start
February 1, 2023
Actual (reported)Primary Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2023
Actual (reported)September 1, 2023
Actual (reported)September 8, 2023
Actual (reported)January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Postoperative month 3 (±15 days), month 6 (±15 days), yearly for 5 years (±30 days)
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Kanna RM, Hajare S, Thippeswamy PB, Shetty AP, Rajasekaran S. Advanced disc degeneration, bi-planar instability and pathways of peri-discal gas suffusion contribute to pathogenesis of intradiscal vacuum phenomenon. Eur Spine J. 2022 Mar;31(3):755-763. doi: 10.1007/s00586-022-07122-0. Epub 2022 Jan 28.
Wang T, Ding W. Risk factors for adjacent segment degeneration after posterior lumbar fusion surgery in treatment for degenerative lumbar disorders: a meta-analysis. J Orthop Surg Res. 2020 Dec 3;15(1):582. doi: 10.1186/s13018-020-02032-7.
Fengzeng Jian, MD,PhD
Xuanwu Hospital, Beijing
First Submitted
September 1, 2023
First Posted
September 8, 2023
Study Start
February 1, 2023
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004 Jul;86(7):1497-503. doi: 10.2106/00004623-200407000-00020.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 8, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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