An observational study in Osteoporotic Vertebral Compression Fractures, sponsored by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · Observational
Osteoporotic vertebral compression fractures are common and painful, especially in older adults. A minimally invasive surgery called vertebral augmentation is often used to relieve pain and stabilize the spine. Diabetes is also very common in these patients. However, it is unclear if having diabetes, especially with poor blood sugar control, makes it harder for patients to recover after this surgery.
This is a retrospective study. The investigators will review the medical records of patients who had this spine surgery at the study hospital between 2022 and 2024. The investigators will look at patients with and without diabetes. The investigators will compare their pain levels, physical function, and whether they experienced new fractures in the two years after surgery. The investigators will use standard statistical methods to analyze this data. No new treatments or tests will be given to patients; the investigators are only looking at past medical records. Patient privacy will be strictly protected.
This study will help doctors understand how diabetes affects recovery after spine surgery. The results may help guide better blood sugar management and bone health treatments for future patients with diabetes and spinal fractures.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's enrollment of 360 is above the median of 100 across 16 observational studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults ≥50 years with OVCF treated by PVP/PKP, complete data, and ≥2-year follow-up.
Three groups:
Target:
360 patients (120/group), 1:1:1 matched for age, sex, BMD T-score, and fracture segment.
Key exclusions:
Multi-segment fracture, prior same-level spine surgery, pathological fracture, spinal infection, severe comorbidities, and inability to complete follow-up.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes patients aged ≥50 years with osteoporotic vertebral compression fracture (OVCF) who underwent percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). Patients had no documented history of diabetes mellitus and, if available, normal preoperative HbA1c levels. The Non-DM group serves as the reference group for comparing postoperative pain relief, functional recovery, bone cement leakage, new vertebral fracture, adjacent vertebral refracture, imaging parameters, and reoperation rate. It represents the baseline outcome profile in patients without diabetes. Each group is targeted to include approximately 120 patients, with 1:1:1 propensity score matching on age, sex, bone mineral density T-score, and fracture segment.
Procedure: Percutaneous Vertebroplasty (PVP) · Procedure: Percutaneous Kyphoplasty (PKP)
This group includes patients with OVCF treated by PVP or PKP who have a documented history of diabetes mellitus and a preoperative HbA1c level below 7.0%. It represents diabetic patients whose blood glucose is adequately controlled before surgery. The main purpose of this group is to determine whether well-controlled diabetes still increases the risk of poor outcomes after vertebral augmentation. If outcomes in this group are similar to the Non-DM group, glycemic control may substantially reduce diabetes-related risk. If outcomes remain worse, diabetes itself may still adversely affect bone quality, healing, or refracture risk. Diabetes duration, glucose-lowering medications, diabetic complications, and postoperative anti-osteoporosis treatment will be recorded. This group will be matched 1:1:1 with the other two groups and compared with both the Non-DM and DM-Poor groups.
Procedure: Percutaneous Vertebroplasty (PVP) · Procedure: Percutaneous Kyphoplasty (PKP)
This group includes patients with OVCF treated by PVP or PKP who have a documented history of diabetes mellitus and a preoperative HbA1c level of 7.0% or higher. It represents diabetic patients with suboptimal glycemic control and a likely higher metabolic burden. This group is central to the primary hypothesis of the study: that poorly controlled diabetes is an independent risk factor for symptomatic adjacent vertebral refracture, worse pain relief, delayed functional recovery, higher bone cement leakage, increased new vertebral fracture, poorer imaging recovery, and higher reoperation rate. The same clinical, surgical, imaging, and follow-up variables will be collected as in the other groups. This group will also be matched 1:1:1 for age, sex, bone mineral density T-score, and fracture segment and compared with the Non-DM and DM-Good groups to isolate the impact of glycemic control status on long-term outcomes after PVP/PKP.
Procedure: Percutaneous Vertebroplasty (PVP) · Procedure: Percutaneous Kyphoplasty (PKP)
This is a retrospective cohort study with no experimental intervention assigned. The study observes patients with osteoporotic vertebral compression fractures (OVCF) who underwent standard percutaneous vertebroplasty (PVP) as part of routine clinical care prior to study enrollment. Surgical indications, techniques, and postoperative management (including glycemic control and anti-osteoporosis treatment) were determined by treating physicians in real-world practice and were not controlled by this study. Patients are retrospectively grouped by pre-existing diabetes status and preoperative HbA1c levels (Non-DM, DM with HbA1c \<7.0%, and DM with HbA1c ≥7.0%) to evaluate long-term outcomes and refracture risk.
This is a retrospective cohort study with no experimental intervention assigned. The study observes patients with osteoporotic vertebral compression fractures (OVCF) who underwent standard percutaneous kyphoplasty (PKP) as part of routine clinical care prior to study enrollment. PKP involves balloon inflation to restore vertebral height before bone cement injection. Surgical indications, techniques, and postoperative management (including glycemic control and anti-osteoporosis treatment) were determined by treating physicians in real-world practice and were not controlled by this study. Patients are retrospectively grouped by pre-existing diabetes status and preoperative HbA1c levels (Non-DM, DM with HbA1c \<7.0%, and DM with HbA1c ≥7.0%) to evaluate long-term outcomes and refracture risk.
Incidence of Symptomatic Adjacent Vertebral Refracture within 2 Years after surgery
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.
Time frame: Within 2 years after the initial percutaneous vertebral augmentation surgery (PVP/PKP).
Change in Visual Analogue Scale (VAS) Score for Back Pain after Percutaneous Vertebral Augmentation
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.
Time frame: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Change in Visual Analogue Scale (VAS) Score for Lower Limb Pain after Percutaneous Vertebral Augmentation
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.
Time frame: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Change in Oswestry Disability Index (ODI) Score after Percutaneous Vertebral Augmentation
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.
Time frame: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Bone Cement Leakage Rate after Percutaneous Vertebral Augmentation
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.
Time frame: During surgery and up to 2 years postoperatively.
Cumulative Incidence of New Vertebral Fractures (Regardless of Adjacency) 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.
Time frame: Within 2 years after surgery.
Local Kyphotic Cobb Angle after Percutaneous Vertebral Augmentation
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.
Time frame: Preoperative, postoperative 1 week, and last follow-up (up to 2 years).
Anterior Vertebral Height Ratio Maintenance Rate after Percutaneous Vertebral Augmentation
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.
Time frame: Preoperative, postoperative 1 week, and last follow-up (up to 2 years).
Reoperation Rate after Percutaneous Vertebral Augmentation
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
Time frame: Within 2 years after the initial PVP/PKP surgery.
Safety Complications after Percutaneous Vertebral Augmentation
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.
Time frame: Within 2 years after the initial PVP/PKP surgery.
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 completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine