Abstract | OBJECTIVE: To determine whether low intensity pulsed ultrasound (LIPUS), compared with sham treatment, accelerates functional recovery and radiographic healing in patients with operatively managed tibial fractures. DESIGN: A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 501 patients, enrolled between October 2008 and September 2012, and followed for one year. SETTING: 43 North American academic trauma centers. PARTICIPANTS: INTERVENTIONS: Patients were allocated centrally to self administer daily LIPUS (n=250) or use a sham device (n=251) until their tibial fracture showed radiographic healing or until one year after intramedullary fixation. MAIN OUTCOME MEASURES: Primary registry specified outcome was time to radiographic healing within one year of fixation; secondary outcome was rate of non-union. Additional protocol specified outcomes included short form-36 (SF-36) physical component summary (PCS) scores, return to work, return to household activities, return to ≥80% of function before injury, return to leisure activities, time to full weight bearing, scores on the health utilities index (mark 3), and adverse events related to the device. RESULTS: SF-36 PCS data were acquired from 481/501 (96%) patients, for whom we had 2303/2886 (80%) observations, and radiographic healing data were acquired from 482/501 (96%) patients, of whom 82 were censored. Results showed no impact on SF-36 PCS scores between LIPUS and control groups (mean difference 0.55, 95% confidence interval -0.75 to 1.84; P=0.41) or for the interaction between time and treatment (P=0.30); minimal important difference is 3-5 points) or in other functional measures. There was also no difference in time to radiographic healing (hazard ratio 1.07, 95% confidence interval 0.86 to 1.34; P=0.55). There were no differences in safety outcomes between treatment groups. Patient compliance was moderate; 73% of patients administered ≥50% of all recommended treatments. CONCLUSIONS: Postoperative use of LIPUS after tibial fracture fixation does not accelerate radiographic healing and fails to improve functional recovery.Study registration ClinicalTrialGov Identifier: NCT00667849.
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Authors | TRUST Investigators writing group, Jason W Busse, Mohit Bhandari, Thomas A Einhorn, Emil Schemitsch, James D Heckman, Paul Tornetta 3rd, Kwok-Sui Leung, Diane Heels-Ansdell, Sun Makosso-Kallyth, Gregory J Della Rocca, Clifford B Jones, Gordon H Guyatt |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 355
Pg. i5351
(Oct 25 2016)
ISSN: 1756-1833 [Electronic] England |
PMID | 27797787
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. |
Topics |
- Adult
- Female
- Fracture Fixation, Intramedullary
(methods)
- Humans
- Male
- Single-Blind Method
- Tibial Fractures
(surgery, therapy)
- Treatment Outcome
- Ultrasonic Therapy
(methods)
- Ultrasonic Waves
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