Prospective Randomized Comparative Study of Percutaneous Vertebroplasty between Unilateral Extrapedicular Approach and Bilateral Transpedicular Approach in Patients with Osteoporotic Vertebral Fracture: Analysis of Bone Cement Volume and Distribution in the Fractured Vertebral Body after Percutaneous Vertebroplasty using Three Dimensional Voxel-based Morphometry

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005688

Enrollment

Registered

2020-12-22

Start date

2021-01-06

Completion date

Unknown

Last updated

2021-01-06

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

Conditions

None listed

Interventions

Procedure/Surgery : Determination of percutaneous vertebroplasty method using random allocation using sealed envelope method. Bilateral transpedicular approach vertebroplasty and unilateral extrapedcu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. BMD (3.0> T-score > -2.5) 2. PVP-treated patient for OVCF 3. age : 30-85

Exclusion criteria

Exclusion criteria: (1) Pathologic fracture: metastatic vertebral fracture, benign or malignant tumor of vertebral body (ex: multiple myeloma) (2) Spinal infection (3) Previous spinal surgery (4) Systemic disease result in osteoporosis (ex: Vitamin D deficiency, Diabetes Mellitus, previous paresis) (5) Patients with multiple compression fracture

Design outcomes

Primary

Measure	Time frame
1.injected bone cement volume,disctribution, 2.subsequent Fx	—

Secondary

Measure	Time frame
1.preop BMD, Preop x-ray (preop 1?),2.postop spine X-ray : KA, SI, vertebral height loss (post op 1,3,6,9,12 months )	—

Countries

Korea, Republic of

Contacts

Public ContactHong-Jae Lee

The Catholic University of Korea, Daejeon St. Mary's Hospital

Outcome results