Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Li Min

Status: Unknown

Conditions: Spine Fracture

Treatments: Device: Conventional Kyphoplasty; Device: Kyphoplasty with Rotary Cutter

Study type: Interventional

Funder types: Other

Identifiers

NCT03850938

960HP20190012

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
2. Patient has read and sign the informed consent
3. Male or female, 50 years or older
4. Compressive and burst vertebral body fractures without any neurological deficit.
5. Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment

Exclusion criteria

1. Neurological signs related to the vertebral fracture to treat
2. Unmanageable bleeding disorder
3. History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
4. Known allergy to bone cement
5. Local or generalized infection
6. Improvement of the symptoms of the patient with conservative management

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Conventional Kyphoplasty

Experimental group

Description:

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.

Treatment:

Device: Conventional Kyphoplasty

Kyphoplasty with Rotary Cutter

Active Comparator group

Description:

The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration, which may induce a cavity with barriers pushed by balloon dilatation. Then, the structure of the cavity is destroyed by a rotary cutter. Finally, the cement is injected, which may effectively interdigitates with the healthy cancellous bone.

Treatment:

Device: Kyphoplasty with Rotary Cutter