A randomized trial comparing the clinical efficacy and safety of a novel steerable percutaneous kyphoplasty with traditional PKP in osteoporotic vertebral fractures

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100046727

Enrollment

Unknown

Registered

2021-05-27

Start date

2022-05-01

Completion date

Unknown

Last updated

2022-01-10

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

Conditions

Thoracolumbar Compression Fracture

Interventions

Group 1:steerable bone drill

Group 2:steerable vertebral dilation balloon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. X-ray, CT, MRI diagnosed as a fresh compression fracture of the thoracic and lumbar spine, accompanied by back pain; 2. Patients with single vertebral compression fractures from the 10th thoracic vertebra to the 5th lumbar vertebra; 3. Using dual energy x-ray to measure bone density (BMD), the bone density is less than -2.5; 4. The patients were followed up for at least one year after surgery.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously undergone PKP or PVP surgery; 2. Patients who cannot cooperate with surgery or require conservative treatment for various reasons; 3. Patients with pathological fractures other than osteoporosis; 4. Patients with symptoms of nerve root or spinal cord compression; 5. Patients with coagulopathy.

Design outcomes

Primary

Measure	Time frame
Cobb angle;Visual analogue scoring;Oswestry dysfunction index questionnaire score;	—

Countries

China

Contacts

Public ContactSong En

641634233@qq.com+86 15912152335

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026