BACKGROUND: The aim of this study was to perform prospective, randomized comparison of two surgical techniques (fixation versus no fixation) and two postoperative regimens (soft cast versus elastic band) to determine if the head fragment displaces more or less with either technique. METHODS:One hundred consecutive patients were included in the study. The osteotomy was fixed with an absorbable pin in 50 cases and no fixation in the other 50. Half of each group used a soft cast for 6 weeks postoperatively and half had a traditional elastic bandage. Weightbearing radiographs at 6 weeks, 6 months, 1 year, and mean of 7.9 years were evaluated. RESULTS: A larger shift was found when fixation was used 3.9 (SD, 0.8) mm at 6 weeks versus 3.1 (SD, 0.9) mm in the no fixation group (p < 0.001). The two bandage types had no significant effect to the mean shift. Correction of the mean hallux valgus angle was worse overall when preoperative angles were over 30 degrees (p < 0.001). CONCLUSION: There was a statistically higher shift in the fixation group, but the clinical significance of 0.7 mm difference and the type of postoperative bandaging did not influence outcome is questionable. The risk for recurrence of hallux valgus was higher when preoperative angles were over 30 degrees.
RCT Entities:
BACKGROUND: The aim of this study was to perform prospective, randomized comparison of two surgical techniques (fixation versus no fixation) and two postoperative regimens (soft cast versus elastic band) to determine if the head fragment displaces more or less with either technique. METHODS: One hundred consecutive patients were included in the study. The osteotomy was fixed with an absorbable pin in 50 cases and no fixation in the other 50. Half of each group used a soft cast for 6 weeks postoperatively and half had a traditional elastic bandage. Weightbearing radiographs at 6 weeks, 6 months, 1 year, and mean of 7.9 years were evaluated. RESULTS: A larger shift was found when fixation was used 3.9 (SD, 0.8) mm at 6 weeks versus 3.1 (SD, 0.9) mm in the no fixation group (p < 0.001). The two bandage types had no significant effect to the mean shift. Correction of the mean hallux valgus angle was worse overall when preoperative angles were over 30 degrees (p < 0.001). CONCLUSION: There was a statistically higher shift in the fixation group, but the clinical significance of 0.7 mm difference and the type of postoperative bandaging did not influence outcome is questionable. The risk for recurrence of hallux valgus was higher when preoperative angles were over 30 degrees.