NCT00667849.
Methods | Randomised controlled trial |
Participants | Patients with tibial fractures treated with intramedullary nailing. Target population = 500 |
Interventions |
Test: LIPUS (low‐intensity pulsed ultrasound) ‐ Exogen (Piscataway, New Jersey) Bone Healing System Control: Sham ultrasound unit |
Outcomes | Primary: radiographs at 6, 12, 18, 26, 38 and 52 weeks Secondary: rates of nonunion of tibial fractures (6, 12, 18, 26, 38 and 52 weeks) |
Notes | This multicentre study, involving centres in USA and Canada, is sponsored by Smith & Nephew (changed to BioventusLLC). It has the same name as the other trial on conservatively treated tibia fractures: TRUST (Pilot). TRUST (Full) has been completed but the data are not yet available (Busse 2013). On 28/06/2013, the trial registration record update on status reported: "The Study was terminated due to futility". The actual population was reported as "501" but a linked report reported: "From July 5th, 2005, to June 22nd, 2007, 51 patients with 14 open and 37 closed tibial fractures were treated with reamed intramedullary nailing". However, the study start date was listed as September 2008 in the trial registration document. The pilot study for this trial (Busse 2014), which recruited 51 patients between March 2006 to June 2007, was published after our date of last search. |