CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
Percutaneous vertebroplasty +1 moredevice
Likely dose
Polymethylmethacrylate (PMMA) injection into vertebral compression fracture via percutaneous vertebroplasty; specific volume/quantity not specifiedAI-extracted
Key inclusion· 4
  • ✓Confirmed osteoporosis or osteopenia by physician, medical history, or imaging (plain film)
  • ✓Vertebral compression fracture in T4–L5 region, less than 1 year old
  • ✓Pain unresponsive to standard medical therapy
  • ✓Current pain intensity ≥3 on 0–10 scale
Key exclusion· 9
  • ✕Evidence or suspicion of malignant tumor or spinal canal compromise
  • ✕Concomitant hip fracture
  • ✕Local or systemic infection
  • ✕Uncorrectable bleeding diatheses

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00068822
NCT00068822Phase 3Completed
CompareCT.gov

Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)

Mayo Clinic·interventional·Posted Sep 11, 2003·Updated Sep 27, 2012

In Brief

A Phase 3 clinical trial evaluating Percutaneous vertebroplasty and Sham vertebroplasty for Spinal Fractures and Osteoporosis. Completed, enrolled 131 participants across 1 site.

Detailed Summary

Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Fractures, Osteoporosis
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2003
Enrollment StartApr 1, 2003
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 22.8 years ago

Interventions

Percutaneous vertebroplastydevice

Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture

Sham vertebroplastyprocedure

Participants, following local anesthesia with lidocaine and bupivacaine, were given verbal and physical cues such as pressure on the back, but the needle was not placed.