NCT03850938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

3.7 years

First QC Date

February 20, 2019

Last Update Submit

February 21, 2019

Conditions

Spine Fracture

Keywords

fractures, compressionback painbone cementskyphoplasty

Outcome Measures

Primary Outcomes (1)

  • Back pain: Visual analogue scales system

    Measuring and comparing the post-operative back pain via Visual analogue scales system

    up to 2 years

Secondary Outcomes (5)

  • 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

  • Medico-economic follow-up

    up to 2 years

Study Arms (2)

Conventional Kyphoplasty

EXPERIMENTAL

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.

Device: Conventional Kyphoplasty

Kyphoplasty with Rotary Cutter

ACTIVE COMPARATOR

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.

Device: Kyphoplasty with Rotary Cutter

Interventions

Conventional KyphoplastyDEVICE

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.

Also known as: Conventional PKP
Conventional Kyphoplasty
Kyphoplasty with Rotary CutterDEVICE

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.

Also known as: PKP with Rotary Cutter
Kyphoplasty with Rotary Cutter

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Min Li

Jinan, Shandong, 250031, China

RECRUITING

MeSH Terms

Conditions

Spinal FracturesFractures, CompressionBack Pain

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, BonePainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

VertebroplastyCementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Director

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

May 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

CN(1)