An observational study in Degenerative Lumbar Disease, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Xuanwu Hospital, Beijing · Observational
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.
Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Patients with low bone mass and degenerative lumbar disease undergoing OLIF without stress endplate augmentation.
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.
Time frame: Postoperative predischarge imaging as the reference and 18 months after surgery; subsidence-related revision surgery assessed through 18 months.
Change in Intervertebral Disc Height
Change in intervertebral disc height, measured in millimeters, from postoperative predischarge imaging to 18 months after surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 18 months after surgery.
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.