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Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

NCT ID: NCT03360383

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-06-01

Brief Summary

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Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.

Detailed Description

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This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.

Conditions

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Spinal Fractures

Keywords

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Spinal Fractures/surgery Vertebroplasty Quality-Adjusted Life Years

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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grade 1

percutaneous vertebroplasty

Group Type EXPERIMENTAL

percutaneous vertebroplasty

Intervention Type PROCEDURE

Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.

grade 2

conservative treatment

Group Type ACTIVE_COMPARATOR

conservative treatment

Intervention Type PROCEDURE

complete on bed with prevention of complications

Interventions

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percutaneous vertebroplasty

Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.

Intervention Type PROCEDURE

conservative treatment

complete on bed with prevention of complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* vertebral compression fracture on spine radiograph (minimum 15% height loss)
* level of fracture at Th5 or lower; back pain for 6 weeks or less
* focal tenderness at fracture level on physical examination
* bone oedema of vertebral fracture on MRI
* decreased bone density (T scores ≤-1)

Exclusion Criteria

* severe cardiopulmonary comorbidity
* suspected underlying malignant disease
* radicular syndrome
* spinal-cord compression syndrome
* contraindication for radiography exam
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu Haiying

Director department of spinal surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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haiying liu

Role: STUDY_DIRECTOR

PekingUPH department of spinal surgery

Central Contacts

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chen guo

Role: CONTACT

Phone: 8618055644700

Email: [email protected]

Other Identifiers

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AVCF1

Identifier Type: -

Identifier Source: org_study_id