Objectives: To determine whether pulsed low-intensity ultrasound (frequency of 1.5 megahertz, pulsed by one kilohertz, signal burst width of 200 microseconds, intensity of thirty milliwatts per square centimeter, and daily treatment time of twenty minutes per day) stimulates regenerate maturation after callus distraction.
Design: Prospective, controlled animal trial.
Methods: Operatively, we created a fifteen-millimeter defect in the right metatarsus of eighteen female mature merino sheep. A segmental transport was begun on Day 5 using a high-stiffness experimental ring fixator. The distraction rate was one millimeter per day divided into two increments of 0.5 millimeters each. On Day 21 after the operation, distraction was finished and the maturation period started and lasted until Day 84 after operation. During this period, Group 1 was treated with a daily twenty-minute low-intensity ultrasound stimulation (frequency of 1.5 megahertz, pulsed by one kilohertz, signal burst width of 200 microseconds, intensity of thirty milliwatts per square centimeter). Group 2 had no stimulation. Animals bore full weight. Plain radiographs in the anteroposterior view were taken every two weeks during the maturation period. After the animals were killed on Day 84, anteroposterior and lateral high resolution radiographs and computed tomography (CT) scans of the regenerate were performed. For each plain and high resolution radiograph, two different relationships (callus relation, the ratio of the amount of periosteal callus to the size of the space between the proximal fragment and transported segment; and interzone relation, the ratio of the fibrous callus interzone to the size of the new formed callus) were calculated. Using CT scan, callus area, bone density, and bone mineral content were evaluated.
Results: The results of interzone relation (both views) and callus relation (lateral view) in high-resolution radiographs and bone mineral content in CT indicate a significantly accelerated maturation of the regenerate in the ultrasound stimulated group even when a Bonferroni–Holm adjustment was used for multiple testing.
Conclusion: Pulsed low-intensity ultrasound appears to stimulate the healing processes in the regenerate in this animal model and may have applicability in clinical practice.
Klinik für Unfall-und Wiederherstellungschirurgie, Augsburg, Germany; and Departments of *Unfallchirurgische Forschung und Biomechanik and †Surgery, Uni Ulm, Ulm, Germany
Accepted September 7, 2000.
Address correspondence and reprint requests to Dr. Edgar Mayr, Klinik für Unfall-und Wiederherstellungschirurgie, Zentralklinikum, Stenglinstr. 2, D-86156 Augsburg, Germany.
The devices discussed in this manuscript are FDA-approved.
This study has been founded by Exogen Inc., Piscataway, New Jersey, U.S.A.