Back to resultsExtended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease
Primary Purpose
Adjacent Segment Degeneration
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
extended one-level interbody fusion
Sponsored by
About this trial
This is an interventional treatment trial for Adjacent Segment Degeneration
Eligibility Criteria
Inclusion Criteria: The age was between 18-60 years old; patients with lumbar degeneration required 1-2 segment interbody fusion, and there were vacuum signs but no symptoms and no instability of the discs in the adjacent segments (power position slip ≤3mm and segmental angle change ≤10°); they agreed with the surgical plan and were willing to undergo long-term clinical follow-up, and signed an informed consent form. Exclusion Criteria: Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
Sites / Locations
- Xuanwu Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06029764
First Posted
September 1, 2023
Last Updated
September 1, 2023
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT06029764
Brief Title
Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease
Official Title
Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 1, 2028 (Anticipated)
Study Completion Date
January 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjacent Segment Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will use a simple randomization method to group patients who meet the inclusion criteria using a computer-generated randomization scheme.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group underwent intervertebral fusion only at the responsible segment.
Intervention Type
Procedure
Intervention Name(s)
extended one-level interbody fusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgical revision rate
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age was between 18-60 years old; patients with lumbar degeneration required 1-2 segment interbody fusion, and there were vacuum signs but no symptoms and no instability of the discs in the adjacent segments (power position slip ≤3mm and segmental angle change ≤10°); they agreed with the surgical plan and were willing to undergo long-term clinical follow-up, and signed an informed consent form.
Exclusion Criteria:
Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Wu, MD,PhD
Phone
13901397527
Email
13901397527@139.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fengzeng Jian, MD,PhD
Phone
135 5206 7268
Email
fengzengjian@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengzeng Jian, MD,PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Study Chair
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Wu, MD,PhD
Phone
139 0139 7527
Email
13901397527@139.com
First Name & Middle Initial & Last Name & Degree
Fengzeng jian, MD,PhD
Phone
135 5206 7268
Email
fengzengjian@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35089418
Citation
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.
Results Reference
result
PubMed Identifier
33272288
Citation
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.
Results Reference
result
PubMed Identifier
15252099
Citation
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.
Results Reference
result
Learn more about this trial
Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease
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