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A Clinical Study of a Modified Minimally Invasive Vertebroplasty for the Treatment of Multilevel Osteoporotic Thoracolumbar Fractures in Elderly Patients

Simultaneous Unilateral Transpedicular Crossed Vertebroplasty for Adjacent Multilevel Osteoporotic Thoracolumbar Vertebral Compression Fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127197
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjacent multilevel thoracolumbar osteoporotic vertebral compression fracture

Interventions

Group 1:Bilateral percutaneous kyphoplasty
Group 2:Sequential Unilateral percutaneous kyphoplasty
Group 3:Cross Unilateral percutaneous kyphoplasty

Sponsors

Rui'an People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >= 60 years; 2.Definitive diagnosis of adjacent >= 2-level thoracolumbar osteoporotic vertebral compression fractures (OVCFs) confirmed by X-ray, CT, and MRI; 3.Significant pain related to fractures, VAS score > 3 points; 4.Bone mineral density examination indicating osteoporosis (T-score = 12 months with the ability to complete follow-up; 8.Significant fracture-related pain with a VAS score > 3.

Exclusion criteria

Exclusion criteria: 1.Vertebral fractures caused by tumors, infection, tuberculosis, or other non-osteoporotic etiologies; 2.Presence of significant neurological deficits requiring decompression or internal fixation surgery; 3.Severe cardiac, pulmonary, hepatic, or renal insufficiency rendering the patient unable to tolerate surgery; 4.Coagulation disorders or long-term anticoagulant therapy that cannot be safely discontinued; 5.Moderate to severe psychiatric disorders or significant cognitive impairment precluding understanding of the study; 6.Previous surgical treatment involving the target vertebrae; 7.Any other conditions deemed inappropriate for enrollment by the investigators.

Design outcomes

Primary

MeasureTime frame
ODI score;Operation time;number of cases with bone cement leakage;SF36 score;intraoperative blood loss;Intraoperative?fluoroscopy;Patients’ anesthesia satisfaction scores;number of perioperative cardiovascular and cerebrovascular adverse events;Investigators’ satisfaction scores;VAS score;Adjacent segment fracture;

Secondary

MeasureTime frame
Hospital day;anterior vertebral body compression ratio of the fractured vertebra;Cement volume;Cobb angle;Hospitalization costs;anesthesia re-administration intention rate;

Countries

China

Contacts

Public ContactHe Shaoqi

Rui'an People's Hospital

heshsoqi@126.com+86 577 58852750

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026