TRAUMA
2013 AAOS Annual Meeting: Trial to evaluate ultrasound in the treatment of tibial fractures (TRUST): A pilot study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):242Exclusive Author Interview
Dr. Busse speaking on the impact of ultrasound treatment for tibial shaft fractures.
51 patients with operatively treated tibial shaft fractures were randomized to either receive low-intensity pulsed ultrasound (LIPUS) or treatment with a deactivated LIPUS device, to determine what the possibility of a definitive trial would be on assessing the impact of LIPUS on patient outcomes. After collecting over a 1 year period recruitment rates, data on patient compliance to treatment, follow-up rates, and data on investigators’ ability to follow study protocol, it was determined that this pilot study supported the probability of a definitive trial in the future.
学会報告
このACE報告は、学会発表または抄録の要約です。提供された情報により、バイアスのリスクや全体的な質の正確な評価を提供することには限界があります。臨床試験が進行中であったり、選択された結果が発表されている可能性があるため、結果を慎重に解釈してください。
なぜ今この研究が必要なのですか？
Due to the nature of tibial fractures, a long recovery period is required. Low-intensity pulsed ultrasound (LIPUS) has been suggested as a treatment that may shorten the healing time. However, it is unclear as to what the impacts of LIPUS are on function. Hence, this study aimed to determine the likelihood of conducting a definitive trial in the future, which would assess the functional and clinical outcomes of LIPUS treatment on operatively treated tibial shaft fractures.
主な研究課題は何ですか？
What was the possibility of conducting a future definitive trial on the functional and clinical outcomes in patients receiving LIPUS treatment for operatively treated tibial shaft fractures, when measured over a 1 year period?
重要な知見は？
- The overall rate of recruitment for this pilot study was 0.8 patients per month, and 84% of patients (43) completed the 1 year follow-up.
- In the LIPUS group 39 patients (76%) fully complied with the use of the ultrasound device, while 12 patients (24%) displayed over 50% obedience to treatment.
- At the 6 month follow-up assessment, patients in the LIPUS group had significantly better SP-36 PCS scores (Mean difference: 6.6; 95% CI: 0.1 to 13.0; p=0.046) and HUI-III scores (Mean difference: 0.20; 95% CI: 0.01 to 0.39; p=0.035) than the Sham group.
- SMFA measures, radiographic healing time, malunion and nonunion rates, and operative and non-operative procedure rates did not differ significantly between groups.
- The tibia fractures that were at risk displayed significant hindrance in functional recovery compared to those fractures that were not at risk, at 9 and 12 months (9 months: p<0.001; 12 months: p=0.03).
最も覚えておくべきことは？
High patient compliance rates and and full investigator adherence to study protocols in this study pilot supported the probability of a definitive trial in the future.
それが私の患者ケアにどのように影響するか？
Currently a trial with a population size of 500 patients assessing the functional and clinical outcomes of LIPUS treatment on operatively treated tibial shaft fractures is being conducted. The results of that study when completed should be able to provide clarity on the effect of LIPUS on radiographic healing time, malunion and nonunion rates, and operative and non-operative procedure rates.
免責事項
このページに記載されている内容は、情報提供のみを目的としたものであり、専門的な医療アドバイス、診断、治療の代わりとなるものではありません。治療が必要な場合は、必ず医師の診断を仰ぐか、最寄りの救急外来を受診してください。このページに記載されている内容に関して個人が表明した意見、信念、見解は、OrthoEvidenceの意見、信念、見解を反映するものではありません。
0の4 月間無料記事のロック解除
