Session V - Pilon / Foot & Ankle

Fri., 10/9/09 Pilon/Foot & Ankle, Paper #62, 5:03 pm OTA-2009

Efficiency of Low-Intensity Pulsed Ultrasound on Distraction Osteogenesis after Trauma: A Prospective, Randomized Study
(FDA=Non-U.S. research conducted within guidelines of my country)

Marcel Dudda, MD1 (n); Jörg Hauser, MD2 (n); Gert Muhr, MD1 (n);
Stefan A. Esenwein, MD1,3 (n);
1Department of Surgery,
2Department of Plastic Surgery,
University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany;
3Department of Orthopaedic Surgery, University Duisburg-Essen, Essen, Germany

Purpose: Low-intensity pulsed ultrasound has been proven to accelerate fracture healing both clinically and experimentally even after major trauma of the lower limb. In this study, the influence of low-intensity pulsed ultrasound during distraction osteogenesis of 40 patients was investigated in a prospective, randomized trial.

Methods: 40 patients with distraction osteogenesis >20 mm could be included in this prospective, randomized study. Both patient groups were comparable regarding their demographic data. The average transportation distance amounted to 669 mm in the group using ultrasound and 631 mm in the control group. 20 patients used low-intensity pulsed ultrasound after independent instruction by physician. The adjunctive ultrasound treatment device was transcutaneously applied (frequency 1.5 MHz, signal burst with 200 microseconds, signal repetition frequency 1.0 kHz, and intensity 30 mW/cm2) for 20 minutes daily. To objectivize the results, the Paley index (month/cm) and Distraction Consolidation index (days/cm) were taken as the basis.

Results: Because of low-intensity pulsed ultrsound therapy, the time of treatment was significantly faster and the Paley and Distraction Consolidation indices were significantly (P <0.05) lower than in the control group (Paley index 0.98 month/cm vs 1.49 months/cm; Distraction Consolidation index 29.36 days/cm vs 44.58 days/cm. Into both groups, an additive cancellous bone graft was necessary; 1 patient of each group had to be amputated. Negative effects of low-intensity pulsed ultrasound during therapy could not be detected.

Conclusion: We conclude that ultrasound treatment can accelerate bone maturation and formation in distraction osteogenesis. The overall treatment time with external fixator will be decreased. In recent literature, a positive effect of ultrasound regarding treatment of pseudarthrosis and fracture healing was described. Now there is a high significance of ultrasound treatment in distraction osteogenesis even after major trauma of the lower limb.

Disclosure: (n=Respondent answered 'No' to all items indicating no conflicts; 1=Board member/owner/officer/committee appointments; 2=Medical/Orthopaedic Publications; 3=Royalties; 4=Speakers bureau/paid presentations; 5A=Paid consultant or employee; 5B=Unpaid consultant; 6=Research or institutional support from a publisher; 7=Research or institutional support from a company or supplier; 8=Stock or Stock Options; 9=Other financial/material support from a publisher; 10=Other financial/material support from a company or supplier).

• The FDA has not cleared this drug and/or medical device for the use described in this presentation   (i.e., the drug or medical device is being discussed for an “off label” use).  ◆FDA information not available at time of printing. Δ OTA Grant