Investigational vertebroplasty efficacy and safety trial: a sham-controlled trial of percutaneous vertebroplasty
| ISRCTN | ISRCTN81871888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81871888 |
| ClinicalTrials.gov number | NCT00068822 |
| Secondary identifying numbers | AR49070-01 |
- Submission date
- 10/10/2003
- Registration date
- 11/11/2003
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Kallmes
Scientific
Scientific
200 1st Street SW
SMH MB M-611
Rochester, MN
55905
United States of America
| Phone | +1 (0)507 255 1964 |
|---|---|
| kallmes.david@mayo.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | INvestigational Vertebroplasty Efficacy and Safety Trial: a sham-controlled trial of percutaneous vertebroplasty |
| Study acronym | INVEST |
| Study objectives | Vertebroplasty is a procedure used to stabilise broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Osteoporosis with painful, crushed or broken vertebra (1 or 2 levels) |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Back-specific functional status using Roland Scale at the one-month time frame. |
| Secondary outcome measures | Health status outcome using 36-item Short Form health survey (SF-36). |
| Overall study start date | 01/12/2003 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 294 |
| Key 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 |
| Key exclusion criteria | 1. Malignant tumour or spinal canal compromise 2. Local or systemic infection 3. Pregnancy 4. Hip fracture |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- United States of America
Study participating centre
200 1st Street SW
Rochester, MN
55905
United States of America
55905
United States of America
Sponsor information
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (National Institutes of Health [NIH]) (USA)
Government
Government
Bethesda
Maryland
20810
United States of America
| Website | http://www.niams.nih.gov/ |
|---|---|
"ROR" |
https://ror.org/006zn3t30 |
Funders
Funder type
Government
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (National Institutes of Health [NIH]) (USA) (ref: AR49373-01)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- The National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Arthritis & Musculoskeletal & Skin Diseases, Instituto Nacional de Artritis y Enfermedades Musculoesqueléticas y de la Piel, NIAMS
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 06/08/2009 | 11/04/2019 | Yes | No |
| Results article | results | 01/10/2013 | 11/04/2019 | Yes | No |
Editorial Notes
11/04/2019: Publication reference added.
21/03/2016: added link to results - basic reporting.
