Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Not Applicable

• Conditions: Spine Fracture
• Interventions: Device: Conventional Kyphoplasty; Device: Kyphoplasty with Rotary Cutter

• Registration Number: NCT03850938
• Lead Sponsor: Li Min

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-22
• Last Update Posted: 2019-02-22
• Study Start: 2019-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Kyphoplasty	Conventional Kyphoplasty	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.
Kyphoplasty with Rotary Cutter	Kyphoplasty with Rotary Cutter	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.

Primary Outcome Measures

Name	Time	Method
Back pain: Visual analogue scales system	up to 2 years	Measuring and comparing the post-operative back pain via Visual analogue scales system

Secondary Outcome Measures

Name	Time	Method
Medico-economic follow-up	up to 2 years	Cost of intervention; Cost of prescribed medicines; Cost of follow-up visits; Cost of subsequent hospitalization; Cost of complications.
Refracture	up to 2 years	Number of new vertebral fractures documented radiologically
Kyphotic angle and global thoracic and lumbar angulations	up to 2 years
The patterns of cement opacification	during the procedure of PKP	The patterns of cement opacification were classified as solid patterns (cement forms a mass), trabecular patterns (cement spread along the fine bone trabeculae), and mixed patterns (cement forms a mass with spreading along the fine bone trabeculae)
Height of the treated vertebral body	Preoperative, up to 2 years	Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements

Trial Locations

Locations (1)

Min Li; 🇨🇳 Jinan, Shandong, China