PURPOSE: This study tested the clinical application of shape-memory clamps for fixation of mandibular fractures using transoral access. MATERIALS AND METHODS: Clamps made of Ti50Ni48.7Co1.3 alloy were used to fix mandible fractures. These clamps automatically recovered their programmed shape at body temperature. The clamps were used to treat all types of fractures occurring between the mandibular angles. Postoperative maxillomandibular fixation was not required. Clamps were removed after a period of at least 6 weeks, and tissue samples were taken for microscopic examination. RESULTS: Seventy-seven patients with mandibular fractures were treated using the shape-memory clamps. There were 19 women and 58 men, from 17 to 74 years old. Altogether 93 fractures were treated, involving 124 clamps. There were 56 cases of single fractures and 21 cases of multiple fractures. In 72 patients the treatment progressed satisfactorily; in five cases infections occurred. Histologic examination of tissue taken from 58 patients after removal of the clamps did not indicate any atypical tissue reactions or signs of disturbed cell maturation. CONCLUSIONS: The application of shape-memory clamps for surgical treatment of mandible fractures facilitates treatment while ensuring stable fixation of the bone fragments. No pathologic tissue reactions to the implants were observed in either animals or humans.
PURPOSE: This study tested the clinical application of shape-memory clamps for fixation of mandibular fractures using transoral access. MATERIALS AND METHODS: Clamps made of Ti50Ni48.7Co1.3 alloy were used to fix mandible fractures. These clamps automatically recovered their programmed shape at body temperature. The clamps were used to treat all types of fractures occurring between the mandibular angles. Postoperative maxillomandibular fixation was not required. Clamps were removed after a period of at least 6 weeks, and tissue samples were taken for microscopic examination. RESULTS: Seventy-seven patients with mandibular fractures were treated using the shape-memory clamps. There were 19 women and 58 men, from 17 to 74 years old. Altogether 93 fractures were treated, involving 124 clamps. There were 56 cases of single fractures and 21 cases of multiple fractures. In 72 patients the treatment progressed satisfactorily; in five cases infections occurred. Histologic examination of tissue taken from 58 patients after removal of the clamps did not indicate any atypical tissue reactions or signs of disturbed cell maturation. CONCLUSIONS: The application of shape-memory clamps for surgical treatment of mandible fractures facilitates treatment while ensuring stable fixation of the bone fragments. No pathologic tissue reactions to the implants were observed in either animals or humans.