Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

Spinal Fractures Clinical Trial

Official title:

Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03360383
• Other study ID #: AVCF1
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 2, 2017
• Start date: February 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: chen guo
• Phone: 8618055644700
• Email: fantasy_g[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Spinal Fractures

Intervention

Procedure:
• percutaneous vertebroplasty
Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
• conservative treatment
complete on bed with prevention of complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of pain relief	World Health Organization pain classification	1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Secondary	quality of life	Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)	1 day, 1 week, 1 month, 3 months, 6 months, and 1 year