Trial · NCT07884149
Impact of Diabetes on Patients With Osteoporotic Vertebral Compression Fractures After Vertebral Augmentation
NCT07884149, Completed, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Diabetes on Patients With Osteoporotic Vertebral Compression Fractures After Vertebral Augmentation. Trials, record NCT07884149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07884149
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Diabetes on Patients With Osteoporotic Vertebral Compression Fractures After Vertebral Augmentation
- NCT number
- NCT07884149
- Status
- Completed
- Enrollment
- 360 participants, actual
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Conditions
- Osteoporotic Vertebral Compression Fractures
- Interventions
- Percutaneous Vertebroplasty (PVP), Percutaneous Kyphoplasty (PKP)
- First posted
- 2026-10-20
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Symptomatic Adjacent Vertebral Refracture within 2 Years after surgery | Within 2 years after the initial percutaneous vertebral augmentation surgery (PVP/PKP). | The primary outcome is the incidence of symptomatic adjacent vertebral refracture occurring within 2 years following percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). A symptomatic adjacent vertebral refracture is defined as a new osteoporotic vertebral compression fracture (OVCF) in a vertebral body immediately adjacent to the previously treated level, confirmed by imaging (X-ray, CT, or MRI) and accompanied by clinical symptoms (e.g., new or worsening back pain). The incidence rate will be compared among three groups: non-diabetic patients (Non-DM), diabetic patients with good glycemic control (HbA1c \< 7.0%), and diabetic patients with poor glycemic control (HbA1c ≥ 7.0%). This outcome will determine whether diabetes mellitus, particularly poor glycemic control, is an independent risk factor for adjacent refracture after PVP/PKP. |
| Secondary | Change in Visual Analogue Scale (VAS) Score for Back Pain after Percutaneous Vertebral Augmentation | Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively. | The VAS is a 0-10 scale (0 = no pain, 10 = worst pain). Back pain VAS will be assessed preoperatively and at 1 week, 3 months, 1 year, and 2 years postoperatively. Changes from baseline and between-group differences among the Non-DM, DM-Good, and DM-Poor groups will be compared to evaluate postoperative pain relief after PVP/PKP. |
| Secondary | Change in Visual Analogue Scale (VAS) Score for Lower Limb Pain after Percutaneous Vertebral Augmentation | Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively. | Lower limb pain VAS will be measured using the same 0-10 scale. Scores will be recorded preoperatively and at 1 week, 3 months, 1 year, and 2 years after surgery. Changes from baseline and differences among the three groups will be analyzed as a secondary indicator of pain relief. |
| Secondary | Change in Oswestry Disability Index (ODI) Score after Percutaneous Vertebral Augmentation | Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively. | The ODI is a validated measure of lumbar functional disability, ranging from 0% to 100%, with higher scores indicating greater disability. ODI will be assessed preoperatively and at 1 week, 3 months, 1 year, and 2 years postoperatively. Changes from baseline and between-group differences will be compared to evaluate functional recovery. |
| Secondary | Bone Cement Leakage Rate after Percutaneous Vertebral Augmentation | During surgery and up to 2 years postoperatively. | Bone cement leakage will be assessed by intraoperative fluoroscopy and postoperative imaging. The presence, location, and type of leakage (e.g., spinal canal, intervertebral disc, paravertebral veins, or soft tissue) will be recorded. The leakage rate will be compared among the Non-DM, DM-Good, and DM-Poor groups. |
| Secondary | Cumulative Incidence of New Vertebral Fractures (Regardless of Adjacency) after surgery | Within 2 years after surgery. | New vertebral fractures include any new osteoporotic vertebral compression fracture in a vertebral body other than the initially treated level, regardless of whether it is adjacent or non-adjacent. Diagnosis will be confirmed by imaging (X-ray, CT, or MRI), with or without symptoms. The cumulative incidence within 2 years will be compared among the three groups. |
| Secondary | Local Kyphotic Cobb Angle after Percutaneous Vertebral Augmentation | Preoperative, postoperative 1 week, and last follow-up (up to 2 years). | The local kyphotic Cobb angle of the treated segment will be measured on lateral radiographs or CT. Measurements will be taken preoperatively, 1 week postoperatively, and at the last follow-up. Changes from baseline and between-group differences will be analyzed to assess sagittal alignment and deformity correction. |
| Secondary | Anterior Vertebral Height Ratio Maintenance Rate after Percutaneous Vertebral Augmentation | Preoperative, postoperative 1 week, and last follow-up (up to 2 years). | The anterior vertebral height ratio will be calculated as the anterior height of the treated vertebral body divided by its estimated normal height. Measurements will be performed preoperatively, 1 week postoperatively, and at the last follow-up. The maintenance rate will be compared among groups to evaluate vertebral height preservation. |
| Secondary | Reoperation Rate after Percutaneous Vertebral Augmentation | Within 2 years after the initial PVP/PKP surgery. | Reoperation is defined as any secondary surgery at the treated level or adjacent levels due to complications, symptomatic refracture, cement displacement, neurological deterioration, or other procedure-related causes. The reoperation rate within 2 years will be compared among the three groups |
| Secondary | Safety Complications after Percutaneous Vertebral Augmentation | Within 2 years after the initial PVP/PKP surgery. | Safety complications include procedure-related or postoperative adverse events such as infection, nerve injury, cement embolism, pulmonary embolism, deep vein thrombosis, and other major complications. All events will be recorded, and the incidence will be compared among the Non-DM, DM-Good, and DM-Poor groups. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07884149
GET https://conductscience.org/api/trials/v1/NCT07884149/registered