1. Study characteristics of unpublished, ongoing and suspended or terminated trials.
Trial registration number | Principle Investigator/s and Country | Comparator/s | Main selection criteria | Registration date | Recruitment commenced | Status 8 January 2018 | Planned sample size | Final sample size |
NCT00749060 ‘OSTEO‐6’ |
Laredo JD France |
Kyphoplasty; Usual care with or without brace | Age ≥ 50 years Fracture < 6 weeks |
8 Sept 2008 | Dec 2007 | Completed June 2012; results unpublished | 300 | 48 |
NCT00749086 ‘STIC2’ |
Laredo JD France |
Kyphoplasty | Age ≥ 50 years Fracture > 6 weeks |
8 Sept 2008 | Dec 2007 | Completed June 2012; results unpublished | 200 | 97 |
NCT00203554 | Sorensen L Denmark |
Usual care | Fracture < 6 months | 16/09/2005 | Mar 2004 | Completed Jan 2008; results unpublished | 27 | 27 |
ISRCTN14442024 (Also N0213112414) |
Dolin, S UK |
Usual care | Fracture > 4 weeks | 12 Sep 2003 | Nov 28 2005 | Completed (last updated 6 Feb 2014); results unpublished | Not provided | Not provided |
NCT01677806 | Sun G China |
Usual care | Age ≥ 50 years Fracture < 6 weeks |
23 Aug 2012 | Oct 2012 | Recruitment status unknown (last updated 11 Sep 2014) | 114 | ‐ |
Registration details not found. | Longo UG Italy |
3 weeks bed rest, rigid hyperextension corset, followed by 2‐3 months in a Cheneau brace (called ‘double‐blind) | Age ≥ 50 years | Trial registration not found | Unknown | Unknown (protocol published) | 200 | ‐ |
NCT01963039 ‘VERTOS V’ |
Carli D the Netherlands |
Sham | Age ≥ 50 years Fracture ≥ 12 weeks |
28 Aug 2013 | May 2013 | Previously reported as completed (Nov 2015) then recruiting again (Feb 2017) (protocol published) | 94 | ‐ |
Record of trial registration not found | Chen JP China |
Usual care | Not available | Trial registration not found | Unknown | Completed; study awaiting translation | Unknown | 84 |
Record of trial registration not found | Li DH China |
Kyphoplasty Bone filling mesh container |
Not available | Trial registration not found | Unknown | Completed; study awaiting translation | Unknown | 90 |
Record of trial registration not found | Tan B China |
Kyphoplasty | Not available | Trial registration not found | Unknown | Completed; study awaiting translation | Unknown | 106 |
Record of trial registration not found | Zhou W China |
Kyphoplasty | Not available | Trial registration not found | Unknown | Completed; study awaiting translation | Unknown | 80 |
* Abstract reported that analysis favoured vertebroplasty at 1 day and 1 week for pain, and disability measured by RMDQ and ODI (data not provided), but no evidence of important differences between groups at 1, 3, 6, 12 months for pain, RMDQ, ODI and SF‐36 function and SF‐36 physical and mental component scores. After 12 months follow‐up, there were 13 new fractures in the percutaneous vertebroplasty group and 11 new fractures in the facet joint block group. Abstract did not report method of randomisation, whether or not treatment allocation was concealed and whether or not participants and investigators were blinded to treatment allocation.