Impact of Diabetes on Patients With Osteoporotic Vertebral Compression Fractures After Vertebral Augmentation

NCT07884149 — Completed, 360 participants, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

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Long-term Impact of Diabetes on Postoperative Outcomes and Risk of Refracture in Patients With Osteoporotic Vertebral Compression Fractures Undergoing Percutaneous Vertebral Augmentation: A Retrospective Cohort Study

Registry	NCT07884149
Status	Completed
Study type	Observational
Enrollment	360 (Actual)
Sponsor	The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine (Other)
Conditions	Osteoporotic Vertebral Compression Fractures
Interventions	Percutaneous Vertebroplasty (PVP), Percutaneous Kyphoplasty (PKP) (Procedure)
Dates	start 2024-09-01, primary completion 2026-09-30, completion 2026-09-30, first posted 2026-10-20, last updated 2026-10-23
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Interventions	Description
Non-Diabetic Control Group (Non-DM)	Procedure: Percutaneous Vertebroplasty (PVP); Procedure: Percutaneous Kyphoplasty (PKP)	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.
Well-Controlled Diabetes Group (DM-Good)	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.
Poorly Controlled Diabetes Group (DM-Poor)	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.

Percutaneous Vertebroplasty (PVP) (Procedure): 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.
Percutaneous Kyphoplasty (PKP) (Procedure): 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.

+Outcome measures

Primary outcomes

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 outcomes

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.
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.
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.
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.
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.
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.
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.
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
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.

+Eligibility

Sex: All

Inclusion Criteria:

1. Imaging-confirmed osteoporotic vertebral compression fracture (OVCF) with corresponding clinical symptoms and signs.
2. Treated with percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP).
3. Age ≥ 50 years at the time of surgery.
4. Complete preoperative and postoperative clinical and imaging data available.
5. Postoperative follow-up of at least 2 years.

Exclusion Criteria:

1. Multi-segment vertebral fractures (≥ 3 segments).
2. Previous same-segment spinal surgery.
3. Pathological fracture.
4. Spinal infection.
5. Secondary hypertension.
6. Severe impairment of cardiac, pulmonary, hepatic, or renal function.
7. Diseases of the gonads, adrenal glands, parathyroid glands, thyroid gland, or pituitary gland.
8. History of immunodeficiency disease (e.g., HIV), cancer or malignant tumor, autoimmune disease, or severe cardiovascular/cerebrovascular disease.
9. Other diseases that may significantly reduce life expectancy.
10. Participation in any drug clinical trial within 6 months before screening.
11. Clear psychiatric history or cognitive impairment that prevents cooperation with follow-up and efficacy evaluation.
12. Any condition that the investigator judges unsuitable for participation in this study.

+Locations (1)

Facility	City	Country	Status
The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405	Guangzhou, Guangdong	China

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