Use of the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures: a prospective cohort study with six months follow-up

Beskrivelse

Background: Pediatric diaphyseal forearm fractures (PDFF) are very common injuries. Fractures needing surgery are most often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal is widely advocated; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) made from poly L-lactide-co-glycolide (PLGA) have been developed for some of the same indications as metal ESIN.
Aim: To evaluate the feasibility and safety of the Activa IM-Nail™ for PDFF.
Materials and Methods: From May 1st 2021 all patients with open physes and unstable PDFF of the radius, ulna or both were sought to be prospectively and consecutively recruited. If consented patients were operated with the Activa IM-Nail™. Primary outcome was radiographic healing assessed by the Radiographic Union Score (RUS) at 3 months. Secondary outcomes were pain, wound appearance, neurovascular status, bilateral elbow and forearm range of motion (ROM), fracture angulation and displacement.
Results: 26 children were eligible for inclusion, 9 children were excluded due to criteria, 17 children were operated with BIN, 7 girls and 10 boys, mean age 10 years (4-14). There were no serious adverse device effects (SADE). Two children had postoperative fracture angulation that did not require manipulation. After 3 months, all patients had pain free and normal ROM. RUS was at least 8 at three months and 10 at six months follow up.
Interpretation / Conclusion: We did not see any SADEs. All children had solid healing and normal ROM at 3 months. The use of BIN for PDFF is feasible, seems very safe, and eliminates the need for implant removal.

Periode	17 nov. 2023
Begivenhedstitel	Dansk Ortopædisk Selskab Kongres 2023
Begivenhedstype	Konference