Functional outcomes, time to union in tibial fractures not improved with LIPUS

SAN DIEGO — Use of low-intensity pulsed ultrasound did not improve function or time to union in patients with acute tibial diaphyseal fractures treated with intramedullary nails, according to results presented here.

“We looked at the functional outcome of the SF-36 [physical component summary] PCS, the health utility index, radiographic healing and secondary outcomes, and found no difference in validated outcome scores, [radiographic union scale for tibial fractures] RUST scores over time, return to function [or] time to weight-bearing,” Paul Tornetta III, MD, on behalf of the TRUST investigators, said in his presentation.

LIPUS device

Tornetta and his colleagues randomly assigned 501 patients who had an acute open or closed fracture of the tibial diaphysis to receive either an active or sham low-intensity pulsed ultrasound (LIPUS) device. All patients were treated with intramedullary nailing. After training, patients used the device once daily. The device was set to an automated 20 minutes and compliance was recorded. Researchers obtained outcomes at 6 weeks, 12 weeks, 18 weeks, 26 weeks and 52 weeks. Tornetta noted available compliance in 424 patients, with 45% of patients using the device 75% or more of the days until union or final follow-up.

Paul Tornetta III
Paul Tornetta III

“An additional 28% used the device more than half of the time, which led to 73% who had more than 50% compliance,” Tornetta said.

He added no significant improvement was found for SF-36 PCS scores in either sham or active device groups. The health utility index also showed no significant difference between the groups, according to results.

According to Tornetta, when it came to secondary outcomes of return to work, leisure activities, back to 80% of function and the time to weight-bearing, no significant differences were found in either group. No difference was also found after sensitivity analysis, he said. Tornetta added that adverse events were similar in both groups.

Limitations

“Early stoppage of 73 patients based on withdraw from the sponsor was one of the limitations we faced, as we did not get the final follow-up on some of those patients. Additionally, we had only 45% compliance for over 75% usage,” Tornetta said.

“[Ultrasound] does not show a statistical difference in any relatively important outcome,” he added. “There is always the question of, ‘Is there an at-risk population that can be addressed with some additional benefit? For instance, diabetics or patients on immunosuppressive medications? We did not have enough patients to do any meaningful subgroup analysis and do not plan to do that analysis.” – by Casey Tingle

Disclosure: Tornetta reports he receives royalties from Smith & Nephew.

SAN DIEGO — Use of low-intensity pulsed ultrasound did not improve function or time to union in patients with acute tibial diaphyseal fractures treated with intramedullary nails, according to results presented here.

“We looked at the functional outcome of the SF-36 [physical component summary] PCS, the health utility index, radiographic healing and secondary outcomes, and found no difference in validated outcome scores, [radiographic union scale for tibial fractures] RUST scores over time, return to function [or] time to weight-bearing,” Paul Tornetta III, MD, on behalf of the TRUST investigators, said in his presentation.

LIPUS device

Tornetta and his colleagues randomly assigned 501 patients who had an acute open or closed fracture of the tibial diaphysis to receive either an active or sham low-intensity pulsed ultrasound (LIPUS) device. All patients were treated with intramedullary nailing. After training, patients used the device once daily. The device was set to an automated 20 minutes and compliance was recorded. Researchers obtained outcomes at 6 weeks, 12 weeks, 18 weeks, 26 weeks and 52 weeks. Tornetta noted available compliance in 424 patients, with 45% of patients using the device 75% or more of the days until union or final follow-up.

Paul Tornetta III
Paul Tornetta III

“An additional 28% used the device more than half of the time, which led to 73% who had more than 50% compliance,” Tornetta said.

He added no significant improvement was found for SF-36 PCS scores in either sham or active device groups. The health utility index also showed no significant difference between the groups, according to results.

According to Tornetta, when it came to secondary outcomes of return to work, leisure activities, back to 80% of function and the time to weight-bearing, no significant differences were found in either group. No difference was also found after sensitivity analysis, he said. Tornetta added that adverse events were similar in both groups.

Limitations

“Early stoppage of 73 patients based on withdraw from the sponsor was one of the limitations we faced, as we did not get the final follow-up on some of those patients. Additionally, we had only 45% compliance for over 75% usage,” Tornetta said.

“[Ultrasound] does not show a statistical difference in any relatively important outcome,” he added. “There is always the question of, ‘Is there an at-risk population that can be addressed with some additional benefit? For instance, diabetics or patients on immunosuppressive medications? We did not have enough patients to do any meaningful subgroup analysis and do not plan to do that analysis.” – by Casey Tingle

Disclosure: Tornetta reports he receives royalties from Smith & Nephew.