Status:
UNKNOWN
Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures
Lead Sponsor:
Li Min
Conditions:
Spine Fracture
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast...
Eligibility Criteria
Inclusion
- Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
- Patient has read and sign the informed consent
- Male or female, 50 years or older
- Compressive and burst vertebral body fractures without any neurological deficit.
- Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment
Exclusion
- Neurological signs related to the vertebral fracture to treat
- Unmanageable bleeding disorder
- History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- Known allergy to bone cement
- Local or generalized infection
- Improvement of the symptoms of the patient with conservative management
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03850938
Start Date
May 1 2019
End Date
December 31 2023
Last Update
February 22 2019
Active Locations (1)
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1
Min Li
Jinan, Shandong, China, 250031