Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
|Spinal Fractures Osteoporosis||Device: Percutaneous vertebroplasty Procedure: Sham vertebroplasty||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)|
- Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month [ Time Frame: 1 month after procedure ]Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.
- Patient's Rating of Average Pain at 1 Month [ Time Frame: 1 month ]Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain.
- Patient Well-being at 1 Month [ Time Frame: Month 1 ]
Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain).
European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL.
Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability.
|Study Start Date:||April 2003|
|Study Completion Date:||September 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Participants will receive percutaneous vertebroplasty
Device: Percutaneous vertebroplasty
Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture
Placebo Comparator: Control Group
Participants will receive sham vertebroplasty without PMMA
Procedure: Sham vertebroplasty
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.
Spontaneous, atraumatic compression fractures due to osteoporosis occur in more than 700,000 patients per year. Pain associated with these fractures may be excruciating, but before the advent of percutaneous vertebroplasty, treatment options were limited. Analgesic medications, bed rest, and bracing have been the mainstays of treatment, but each of these therapies has substantial limitations.
Because of the dearth of viable treatment options for osteoporotic vertebral compression fractures, the practice of percutaneous vertebroplasty, which involves injection of polymethylmethacrylate (medical cement) into the fractured vertebra, has disseminated rapidly. However, evidence for the efficacy of percutaneous vertebroplasty is currently limited to uncontrolled, nonblinded, small case studies. Even though high rates of success are reported, with up to 90% of patients achieving substantial pain relief, these case studies have not accounted for numerous important potential biases, including the natural tendency for compression fractures to heal spontaneously, regression toward the mean (wherein patients seek medical attention when pain is maximum), and the placebo effect. This study will examine the clinical efficacy of percutaneous vertebroplasty for treatment of painful osteoporotic vertebral compression fractures.
Participants in this study will be randomly assigned to receive either percutaneous vertebroplasty or a sham procedure (placebo control group). Participants may have up to 2 spinal levels treated. Participants will be enrolled in the study for 1 year and will have study visits at entry and Months 1 and 12. There will also be phone visits at Days 1, 2, 3, and 14 and Months 3 and 6. After Month 1, crossover from the placebo group to the vertebroplasty group will be allowed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068822
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||David F. Kallmes, MD||Mayo Clinic|