NCT03850938

Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Li Min · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spine Fracture

Interventions

Type	Name	Description
DEVICE	Conventional Kyphoplasty	The cement is injected into the cavity created by PKP. The diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones.
DEVICE	Kyphoplasty with Rotary Cutter	The rotary cutter is applied before cement injection to destroy the structure around the cavity created by inflated balloon. Then, the rotary cutter will make the bone cement to support a wider range and to blend with the surrounding cancellous bones more densely.

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2019-02-22
• Last updated: 2019-02-22

Locations

1 site across 1 country: China