UnknownNot Applicable

Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty

China500 participantsStarted 2023-12-01

Plain-language summary

"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures."

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
✓. No history of high-energy trauma;
✓. Patient complains of pain in the lumbar region, confirmed by MRI showing a newly developed vertebral fracture from T5 to L5 (i.e., MRI shows low signal on T1 and high or slightly high signal on T2);
✓. Has undergone Percutaneous Vertebroplasty (PVA) treatment.

Exclusion criteria

✕. Incomplete imaging or medical record data;
✕. History of spinal surgeries other than PVA;
✕. Pre-existing symptoms of spinal cord compression or nerve root injury;
✕. Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
✕. Chronic conditions like Kummell's disease or non-union of old fractures;
✕. Concurrent vertebral burst fractures;
✕. Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure;
✕. History of violent trauma after PVA procedure.

What they're measuring

secondary vertebral fractures

Timeframe: 2 years post-operative

Trial details

NCT IDNCT06172179

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-01

Contact for this trial

Chunhai Li, MD

18602079796 lichhai@mail.sysu.edu.cn

View on ClinicalTrials.gov More Osteoporotic Vertebral Fracture trials