A randomised controlled trial of vertebroplasty for the treatment of osteoporotic vertebral crush fractures
| ISRCTN | ISRCTN14442024 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14442024 |
| Protocol serial number | N0213112414 |
| Sponsor | Department of Health (UK) |
| Funder | Royal West Sussex Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Dolin
Scientific
Scientific
Pain Service
St Richards Hospital
Spitalfield Lane
Chichester
PO19 4SE
United Kingdom
| Phone | +44 (0)1243 788122 |
|---|---|
| Simon.Dolin@rws-tr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of vertebroplasty for the treatment of osteoporotic vertebral crush fractures |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Osteoporetic crush fractures |
| Intervention | Randomised to vertebroplasty or best medical treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | 1. History of vertebral crush fractures proven on radiograph 2. Causes of crush fractures other than osteoporosis excluded 3. Persistent moderate/severe pain after 4 weeks conservative treatment 4. No more than four fractures |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 28/11/2005 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Richards Hospital
Chichester
PO19 4SE
United Kingdom
PO19 4SE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/10/2016: No publications found, verifying study status with principal investigator.
