Status:
UNKNOWN
Percutaneous Vertebroplasty Versus Conservative Treatment in GIOPVCF
Lead Sponsor:
Peking University First Hospital
Conditions:
Osteoporosis
Eligibility:
All Genders
55-75 years
Brief Summary
Based on the case reports and other literature, the investigators hypothesize that using PVP for treating GIOPVCF is associated with increased risk of vertebral refractures and does not provide furthe...
Detailed Description
Patient recruitment and informed consent The study will recruit patients with GIOPVCF after consultation with inpatients and outpatients. The principal investigator of the study will screen the clinic...
Eligibility Criteria
Inclusion
- Patients have fresh vertebral compression fractures regarding spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone edema on MRI, focal tenderness on VCF level).
- Patients have back pain for 6 weeks or less, with a visual analogue scale (VAS) score equal or less than 5.
- GCs consumption for more than 3 months (prednisone equivalent or more than 5 mg daily).
- Reduced bone density with T-scores equal or less than -1.
- Age at 55 or higher.
- \-
Exclusion
- Concurrent other secondary osteoporosis.
- Previous PVP procedure or other spinal surgery on thoracic or lumbar segments.
- Systemic or local infection in spine (osteomyelitis, spondylodiscitis)
- Unable to comply with study due to severe psychosis.
- \-
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03330340
Start Date
December 1 2017
End Date
December 30 2019
Last Update
November 6 2017
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