Ultrasonically assisted anchoring of biodegradable implants for chevron osteotomies - clinical evaluation of a novel fixation method.

UNLABELLED

Reconstructive osteotomies for the treatment of Hallux valgus are among the most prevalent procedures in foot and ankle surgery. The combination of biodegradable materials with an innovative method for fixation by application of ultrasonic energy facilitates a new bonding method for fractures or osteotomies. As clinical experience is still limited, the aim of this study was to assess the safety and performance of the SonicPin system for fixation of Austin/Chevron osteotomies. Chevron osteotomy was performed on 30 patients for the treatment of Hallux valgus. The used SonicPins were made from polylactide and are selectively melted into the cancellous bone structure during insertion by ultrasonic energy. Patients were followed for one year, which included X-ray and MRI examinations as well as evaluation of life quality by EQ-5D (EuroQol). The MRI after three months showed adequate bone healing in all cases and no signs of foreign body reactions, which was again confirmed by MRI 12 months postoperatively. The bony healing after 12 months was uneventful without any signs of foreign body reactions. In summary, based on the low complication rate and the significant improvement in health related quality of life (EQ-5D) reported in this study, fixation of an Austin/Chevron osteotomy with a SonicPin for treatment of Hallux valgus can be considered to be safe and efficient over the short term.

LEVEL OF CLINICAL EVIDENCE

Therapeutic Level III.