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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 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. |
|
| control group | No Intervention | The control group underwent intervertebral fusion only at the responsible segment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended one-level interbody fusion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Wu, MD,PhD | Contact | 13901397527 | 13901397527@139.com | |
| Fengzeng Jian, MD,PhD | Contact | 135 5206 7268 | fengzengjian@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fengzeng Jian, MD,PhD | Xuanwu Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35089418 | Result | 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. | |
| 33272288 | Result |
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This study will use a simple randomization method to group patients who meet the inclusion criteria using a computer-generated randomization scheme.
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| 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. |
| 15252099 | Result | 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. |