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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR049373 | U.S. NIH Grant/Contract | View source | |
| NIAMS-096 | |||
| UL1RR025014 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertebroplasty | Experimental | Participants will receive percutaneous vertebroplasty |
|
| Control Group | Placebo Comparator | Participants will receive sham vertebroplasty without PMMA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous vertebroplasty | Device | Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month | Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability. | 1 month after procedure |
| Patient's Rating of Average Pain at 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Well-being at 1 Month | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David F. Kallmes, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14519867 | Background | Kallmes DF, Jensen ME. Percutaneous vertebroplasty. Radiology. 2003 Oct;229(1):27-36. doi: 10.1148/radiol.2291020222. | |
| 19657122 | Result | Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563. |
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Participants were enrolled at five centers in the U.S., five centers in the United Kingdom and one center in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vertebroplasty, Then Control | Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) |
| FG001 | Control, Then Vertebroplasty | Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Randomized Intervention |
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| ||||||||||||||||||
| Optional Crossover Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vertebroplasty | Participants will receive percutaneous vertebroplasty |
| BG001 | Control Group | Participants will receive partial vertebroplasty without PMMA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month | Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability. | 68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month. | Posted | Mean | Standard Deviation | units on a scale | 1 month after procedure |
|
12 months from baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vertebroplasty | Participants will receive percutaneous vertebroplasty |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical injury | Injury, poisoning and procedural complications | Non-systematic Assessment | One participant in the vertebroplasty group had an injury to the thecal sac during the procedure resulting in hospitalization. |
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The possible role of the placebo effect on outcomes remains unclear. Crossover at 1 month was allowed, which complicated the interpretation of between-group outcome differences. Other medical treatments received were not compared to study groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David F. Kallmes, M.D. | Mayo Clinic | 507-266-3350 | kallmes.david@mayo.edu |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| D010024 | Osteoporosis |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Sham vertebroplasty | Procedure | 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. |
|
| Month 1 |
| 23696683 | Derived | Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21. |
| Crossover at Month 3 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| RDQ Score at baseline | Scores on the Roland-Morris Disability Questionnaire (RDQ) range from 0-23, with higher scores indicating more severe disability | Mean | Standard Deviation | Units on a scale |
|
| Average pain intensity during past 24 hours at baseline | The pain intensity rating ranges from 0 (no pain) to 10 (worst pain) | Mean | Standard Deviation | Units on a scale |
|
| SF-36 score; summary physical component at baseline | 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). | Mean | Standard Deviation | Units on a scale |
|
| SF-36 score; summary mental component at baseline | 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). | Mean | Standard Deviation | Units on a scale |
|
| Pain Frequency Index Score at baseline | Scores on the Pain Frequency Index range from 0 to 4, with higher scores indicating more severe pain | Mean | Standard Deviation | Units on a scale |
|
| Pain Bothersome Index score at baseline | Scores on the Pain Bothersome Index range from 0 to 4, with higher scores indicating more severe pain | Mean | Standard Deviation | Units on a scale |
|
| EQ-SD Score at baseline | European Quality of Life - 5 Dimensions (EQ-SD) scale range from -0.1 to 1.0, with higher scores indicating a better quality of life. | Mean | Standard Deviation | Units on a scale |
|
| SOF-ADL Score at baseline | Study of Osteoporotic Fractures - Activities of Daily Living (SOF-ADL) scale range from 0 to 18, with higher scores indicating more back-related disability | Mean | Standard Deviation | Units on a scale |
|
Participants will receive partial vertebroplasty without PMMA
|
|
|
| Secondary | Patient Well-being at 1 Month | 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. | 68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month. | Posted | Mean | Standard Deviation | units on a scale | Month 1 |
|
|
|
|
| Primary | Patient's Rating of Average Pain at 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. | 68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
|
|
| 1 |
| 68 |
| 0 |
| 68 |
| EG001 | Control Group | Participants will receive partial vertebroplasty without PMMA | 1 | 61 | 0 | 61 |
|
| Tachycardia and rigors | Cardiac disorders | Non-systematic Assessment | One patient in the control group was hospitalized overnight after the procedure with tachycardia and rigors of unknown cause |
|
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| D001851 |
| Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pain frequency index score |
|
| Pain bothersome index score |
|
| EQ-5D score |
|
| SOF-ADL score |
|
| 0.83 |
| Treatment Effect |
| 1.0 |
| 2-Sided |
| 95 |
| -3.7 |
| 4.6 |
| No |
| Superiority or Other |
| Pain Frequency Index treatment effect | ANCOVA | 0.33 | Treatment Effect | 0.2 | 2-Sided | 95 | -0.2 | 0.6 | No | Superiority or Other |
| Pain Bothersome Index treatment effect | ANCOVA | 0.33 | Treatment Effect | 0.33 | 2-Sided | 95 | -0.2 | 0.6 | No | Superiority or Other |
| EQ-5D Index treatment effect | ANCOVA | 0.13 | Treatment Effect | 0.05 | 2-Sided | 95 | -0.01 | 0.11 | No | Superiority or Other |
| SOF-ADL treatment effect | ANCOVA | 0.5 | Treatment Effect | 0.4 | 2-Sided | 95 | -0.8 | 1.6 | No | Superiority or Other |