Degenerative Lumbar DiseaseNCT07891663
Comparing Lumbar Fusion With and Without Stress Endplate Augmentation in Patients With Low Bone Mass
An observational study of Degenerative Lumbar Disease, run by Xuanwu Hospital, Beijing.
Trial summary
Degenerative lumbar disease can cause back pain, leg pain, and difficulty with daily activities. Some patients require lumbar fusion surgery. In patients with low bone mass, the bones may provide less support for the interbody cage, an implant placed between two vertebrae. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Lumbar Disease
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive eligible patients aged 50 years or older with low bone mass and symptomatic degenerative lumbar disease who are scheduled to undergo oblique lumbar interbody fusion (OLIF) at Xuanwu Hospital, Capital Medical University. Patients will be enrolled before surgery and followed prospectively for 18 months.
Who may be able to join
- Age 50 years or older.
- Degenerative lumbar disease diagnosed clinically and by imaging, including lumbar spinal stenosis, degenerative spondylolisthesis, or degenerative disc disease.
- Persistent symptoms despite appropriate nonsurgical treatment, with a clinical indication for surgery.
- Scheduled to undergo oblique lumbar interbody fusion (OLIF).
- Low bone mass identified by preoperative dual-energy X-ray absorptiometry (DXA), defined as a T-score below -1.0 at a valid measurement site.
- Ability and willingness to complete the required imaging examinations, patient-reported outcome assessments, and follow-up through 18 months after surgery.
- Ability to understand the study and provision of written informed consent before enrollment.
Who cannot join
- Previous lumbar spine surgery.
- Nondegenerative lumbar conditions, including spinal infection, tumor, or acute trauma.
- Severe vertebral compression fracture.
- Grade II or higher lumbar spondylolisthesis, or spinal deformity requiring complex osteotomy or other major corrective surgery.
- Inability to complete the required imaging examinations or scheduled follow-up.
- Other conditions that, in the investigator's judgment, make participation unsuitable.
About this study
Official title: Radiographic and Clinical Outcomes of Stress Endplate Augmentation in Patients With Low Bone Mass Undergoing Oblique Lumbar Interbody Fusion for Degenerative Lumbar Disease: A Prospective Observational Cohort Study
Degenerative lumbar disease can cause back pain, leg pain, and difficulty with daily activities. Some patients require lumbar fusion surgery. In patients with low bone mass, the bones may provide less support for the interbody cage, an implant placed between two vertebrae. The cage may sink into the surrounding bone after surgery, a complication known as cage subsidence. Stress endplate augmentation strengthens the bone near the surfaces supporting the cage, but its benefits and risks require further evaluation.
This single-center prospective observational cohort study will compare outcomes in patients undergoing oblique lumbar interbody fusion (OLIF) with or without stress endplate augmentation. Consecutive eligible patients aged 50 years or older with low bone mass and degenerative lumbar disease will be enrolled before surgery and followed for 18 months afterward.
Read more
Whether stress endplate augmentation is performed will be determined by the treating surgeon and patient through routine clinical decision-making. The study will not assign treatment. Patients will be grouped according to whether they receive stress endplate augmentation.
The main outcome will be cage subsidence at 18 months after surgery. Other outcomes will include spinal fusion, changes in spinal measurements on imaging, back and leg pain, functional disability, surgical and hospitalization measures, and complications.
Clinical information, bone density measurements, imaging findings, and patient-reported outcomes will be collected before surgery and during follow-up. Comparisons will account for differences in patient characteristics and surgical factors. The study aims to clarify the benefits and risks associated with stress endplate augmentation in patients with low bone mass undergoing OLIF.
- Conditions
- Degenerative Lumbar Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OLIF With Stress Endplate Augmentation | Patients with low bone mass and degenerative lumbar disease undergoing oblique lumbar interbody fusion (OLIF) with stress endplate augmentation of the vertebral bone adjacent to the endplates supporting the interbody cage. | |
| OLIF Without Stress Endplate Augmentation | Patients with low bone mass and degenerative lumbar disease undergoing OLIF without stress endplate augmentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cage Subsidence at 18 Months After Surgery
Number of participants with interbody cage subsidence, defined as a decrease of more than 2 mm in intervertebral disc height at any operated level compared with the postoperative predischarge imaging reference. A participant with subsidence at one or more operated levels is counted once. Participants undergoing revision surgery for cage subsidence before the 18-month assessment are also counted as having the outcome.
Measured: Postoperative predischarge imaging as the reference and 18 months after surgery; subsidence-related revision surgery assessed through 18 months.
Secondary outcomes (5)
Change in Intervertebral Disc Height
Change in intervertebral disc height, measured in millimeters, from postoperative predischarge imaging to 18 months after surgery.
Measured: 18 months after surgery.
Change in Intervertebral Foraminal Height
Change in intervertebral foraminal height, measured in millimeters, from postoperative predischarge imaging to 18 months after surgery.
Measured: 18 months after surgery.
Change in Lumbar Lordosis at 18 Months
Change in lumbar lordosis, measured in degrees, from postoperative predischarge imaging to 18 months after surgery.
Measured: 18 months after surgery.
Number of Participants With Pseudarthrosis
Number of participants with radiographic pseudarthrosis at one or more operated levels at 18 months after surgery. For this study, pseudarthrosis is defined as radiographic nonunion on CT, classified as Bridwell grade III (an intact graft with radiolucency at the superior or inferior graft-endplate interface) or grade IV (absent fusion with graft resorption or collapse). Each participant is counted once, regardless of the number of affected levels.
Measured: 18 months after surgery.
Functional Improvement
Change in the Oswestry Disability Index (ODI) score from baseline to 18 months after surgery. The ODI measures back-related disability, with scores ranging from 0 to 100 and higher scores indicating greater disability. Change is calculated as the 18-month score minus the baseline score; negative values indicate improvement.
Measured: Baseline and 18 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891663
- Sponsor's protocol ID
- Xuanwu-SEA-2026-01
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Clinical Outcomes of Stress Endplate Augmentation in Patients With Low Bone Mass Undergoing Oblique Lumbar Interbody Fusion for Degenerative Lumbar Disease: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07891663
- Acronym / sponsor ID
- Xuanwu-SEA-2026-01
- Conditions
- Degenerative Lumbar Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Degenerative lumbar disease can cause back pain, leg pain, and difficulty with daily activities. Some patients require lumbar fusion surgery. In patients with low bone mass, the bones may provide less support for the interbody cage, an implant placed between two vertebrae. The cage may sink into the surrounding bone after surgery, a complication known as cage subsidence. Stress endplate augmentation strengthens the bone near the surfaces supporting the cage, but its benefits and risks require further evaluation.
This single-center prospective observational cohort study will compare outcomes in patients undergoing oblique lumbar interbody fusion (OLIF) with or without stress endplate augmentation. Consecutive eligible patients aged 50 years or older with low bone mass and degenerative lumbar disease will be enrolled before surgery and followed for 18 months afterward.
Whether stress endplate augmentation is performed will be determined by the treating surgeon and patient through routine clinical decision-making. The study will not assign treatment. Patients will be grouped according to whether they receive stress endplate augmentation.
The main outcome will be cage subsidence at 18 months after surgery. Other outcomes will include spinal fusion, changes in spinal measurements on imaging, back and leg pain, functional disability, surgical and hospitalization measures, and complications.
Clinical information, bone density measurements, imaging findings, and patient-reported outcomes will be collected before surgery and during follow-up. Comparisons will account for differences in patient characteristics and surgical factors. The study aims to clarify the benefits and risks associated with stress endplate augmentation in patients with low bone mass undergoing OLIF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLIF With Stress Endplate Augmentation | – | –Patients with low bone mass and degenerative lumbar disease undergoing oblique lumbar interbody fusion (OLIF) with stress endplate augmentation of the vertebral bone adjacent to the endplates supporting the interbody cage. |
| OLIF Without Stress Endplate Augmentation | – | –Patients with low bone mass and degenerative lumbar disease undergoing OLIF without stress endplate augmentation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive eligible patients aged 50 years or older with low bone mass and symptomatic degenerative lumbar disease who are scheduled to undergo oblique lumbar interbody fusion (OLIF) at Xuanwu Hospital, Capital Medical University. Patients will be enrolled before surgery and followed prospectively for 18 months.
Key inclusion criteria (7 listed)
- Age 50 years or older.
- Degenerative lumbar disease diagnosed clinically and by imaging, including lumbar spinal stenosis, degenerative spondylolisthesis, or degenerative disc disease.
- Persistent symptoms despite appropriate nonsurgical treatment, with a clinical indication for surgery.
- Scheduled to undergo oblique lumbar interbody fusion (OLIF).
- Low bone mass identified by preoperative dual-energy X-ray absorptiometry (DXA), defined as a T-score below -1.0 at a valid measurement site.
Key exclusion criteria (6 listed)
- Previous lumbar spine surgery.
- Nondegenerative lumbar conditions, including spinal infection, tumor, or acute trauma.
- Severe vertebral compression fracture.
- Grade II or higher lumbar spondylolisthesis, or spinal deformity requiring complex osteotomy or other major corrective surgery.
- Inability to complete the required imaging examinations or scheduled follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cage Subsidence at 18 Months After Surgery
Time frame: Postoperative predischarge imaging as the reference and 18 months after surgery; subsidence-related revision surgery assessed through 18 months.
Number of participants with interbody cage subsidence, defined as a decrease of more than 2 mm in intervertebral disc height at any operated level compared with the postoperative predischarge imaging reference. A participant with subsidence at one or more operated levels is counted once. Participants undergoing revision surgery for cage subsidence before the 18-month assessment are also counted as having the outcome.
5 secondary outcomes
Change in Intervertebral Disc Height
Time frame: 18 months after surgery.
Change in Intervertebral Foraminal Height
Time frame: 18 months after surgery.
Change in Lumbar Lordosis at 18 Months
Time frame: 18 months after surgery.
Number of Participants With Pseudarthrosis
Time frame: 18 months after surgery.
Functional Improvement
Time frame: Baseline and 18 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Disease, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cage Subsidence at 18 Months After Surgery (time frame: Postoperative predischarge imaging as the reference and 18 months after surgery; subsidence-related revision surgery assessed through 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.