Investigational vertebroplasty efficacy and safety trial: a sham-controlled trial of percutaneous vertebroplasty

Not Applicable

Completed

• Conditions: Osteoporosis with painful, crushed or broken vertebra (1 or 2 levels); Musculoskeletal Diseases; Osteoporosis

• Registration Number: ISRCTN81871888
• Lead Sponsor: ational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (National Institutes of Health [NIH]) (USA)

Brief Summary

1. 2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19657122 (added 11/04/2019) 2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23696683 (added 11/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-11-11
• Study Completion: 2008-12-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

1. Over 50 years old
2. Confirmed osteoporosis or osteopenia
3. Painful vertebral fracture
4. Refractory to medical therapy
5. No previous vertebroplasty or kyphoplasty
6. No infections or immunocompromised patients

Exclusion Criteria

1. Malignant tumour or spinal canal compromise
2. Local or systemic infection
3. Pregnancy
4. Hip fracture

Study & Design

• Study Type: Interventional
• Study Design: Not specified