Clinical Results and Technical Note of a Novel Therapeutic Method for Distal Tibial Fracture: A Multicenter Prospective Study on the Use of the Distal Tibial Nail

Introduction: The distal tibial nail (DTN) is a novel technique that was developed and characterized as a retrograde intramedullary nail for distal tibial fracture. We investigated the clinical results of the use of DTN for distal tibial fractures in multiple centers and compared them with the literature on the treatment results of locking plates and antegrade intramedullary nails. Materials and methods: This multicenter, prospective observational study (cohort) examined 10 cases of distal tibial fractures with an AO/OTA classification of 43 Types A1, A2, A3 or Type C1. The primary outcomes were bone union rate, soft tissue problems, and complications associated with surgical procedures. The secondary outcomes were the EuroQol-5 Dimension-5 Level (EQ-5D-5L), Self-Administered Foot Evaluation Questionnaire (SAFE-Q), and American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scale as clinical scores at 1 year after surgery. The incidence of varus or valgus/anterior-posterior flexion deformity with a difference of ≥ 5° and the postoperative reduction loss rate were evaluated.Results: The patients included five men and five women, with a median age of 69 years (30–77), and one open fracture of type Gustilo IIIB. Bone union was observed in all cases at 6 months postoperatively. Delayed union was observed in three cases, and leg edema and guide pin breakage were observed in one case each. Soft tissue problems or complications associated with the surgical procedure were not observed. During the final follow-up, EQ-5D-5L was 0.876 (0.665-1.0), SAFE-Q was 83-92 points, and the AOFAS hindfoot scale was 92.6 points (76–100). Varus deformity and retroflexion deformity were observed in one case each. Conclusion: The treatment results of DTN for distal tibial fractures were as good as those of locking plates and antegrade intramedullary nails reported in the literature. DTN is a useful stabilization tool and does not additionally compromise the surrounding soft tissues.