Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures
Overview
- Phase
- Not Applicable
- Sponsor
- Li Min
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Back pain: Visual analogue scales system
Overview
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 agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Back pain: Visual analogue scales system
Time Frame: up to 2 years
Measuring and comparing the post-operative back pain via Visual analogue scales system
Secondary Outcomes
- Medico-economic follow-up(up to 2 years)
- Refracture(up to 2 years)
- Kyphotic angle and global thoracic and lumbar angulations(up to 2 years)
- The patterns of cement opacification(during the procedure of PKP)
- Height of the treated vertebral body(Preoperative, up to 2 years)
Investigators
Li Min
Vice Director
Jinan Military General Hospital