Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Spine Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03850938
• Other study ID #: 960HP20190012
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2019
• Source: Jinan Military General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures
• Spine Fracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Min Li	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Li Min

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Back pain: Visual analogue scales system	Measuring and comparing the post-operative back pain via Visual analogue scales system	up to 2 years
Secondary	Refracture	Number of new vertebral fractures documented radiologically	up to 2 years
Secondary	Kyphotic angle and global thoracic and lumbar angulations		up to 2 years
Secondary	The patterns of cement opacification	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)	during the procedure of PKP
Secondary	Height of the treated vertebral body	Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements	Preoperative, up to 2 years
Secondary	Medico-economic follow-up	Cost of intervention; Cost of prescribed medicines; Cost of follow-up visits; Cost of subsequent hospitalization; Cost of complications.	up to 2 years