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Clinical efficacy comparison of unilateral balloon dilation with unilateral stent placement and bilateral balloon dilation with unilateral stent placement for the treatment of vertebral compression fractures

Clinical efficacy comparison of unilateral balloon dilation with unilateral stent placement and bilateral balloon dilation with unilateral stent placement for the treatment of vertebral compression fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126025
Enrollment
Unknown
Registered
2026-06-02
Start date
2025-01-13
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

vertebral compression fracture

Interventions

Bilateral balloon dilatation and unilateral stent placement surgery group:Bilateral percutaneous endoscopic vertebral body fusion with balloon dilation followed by placement of a single VBS stent.
Single-sided balloon dilatation and single-sided stent placement surgery group:Unilateral transpedicular balloon dilation of the vertebral body followed by placement of a single VBS stent

Sponsors

Beijing Friendship Hospital Affiliated with Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age 60 years or older; 2. Acute single vertebral (T10-L5) osteoporotic vertebral compression fracture (MRI shows low signal intensity on T1-weighted images and high signal intensity on T2-weighted images and STIR sequences); 3.Loss of more than one-third of the anterior or middle margin of the vertebral body; 4.Complete preoperative and postoperative clinical records available; 5.Patients able to sign informed consent forms independently and willing to complete follow-up.

Exclusion criteria

Exclusion criteria: 1.Multiple segmental osteoporotic vertebral compression fractures; 2.Evidence of bone tumors or other bone metabolic diseases; 3.CT scan indicating incomplete or fractured posterior wall of the fractured vertebra; 4.Contraindications for surgery, such as coagulation abnormalities or severe organ lesions; 5.Patients who have been bedridden for a long time; 6.Lack of informed consent.

Design outcomes

Primary

MeasureTime frame
Midline height of the vertebral body;Visual Analogue Scale (VAS) for low back pain;ODI score;Vertebral body anterior margin height;Cobb angle;wedge angle;Vertebral body kyphotic angle;

Secondary

MeasureTime frame
Surgery time;Intraoperative fluoroscopy dose;

Countries

China

Contacts

Public ContactQi Fei

Beijing Friendship Hospital Affiliated with Capital Medical University

spinefei@126.com+86 136 4122 5060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026