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COMPLETED
NCT07884149

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

Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

360

Start Date

2024-09-01

Completion Date

2026-09-30

Last Updated

2026-10-23

Healthy Volunteers

Not specified

Interventions

PROCEDURE

Percutaneous Vertebroplasty (PVP)

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.

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 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.

Locations (1)

The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405

Guangzhou, Guangdong, China