Intramedullary nailing of forearm shaft fractures by biodegradable compared with titanium nails: Results of a prospective randomized trial in children with at least two years of follow-up.

There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm-shaft fractures, such as the need of implant removal. Biodegradable Intramedullary Nailing (BIN) is a new technique developed for these fractures. We hypothesized that there is no difference in rotational ROM between the patients treated by BIN vs. ESIN. A randomized, controlled clinical trial included patients, aged 5-15 years, requiring surgery for forearm-shaft fractures. Biodegradable polylactide-co-glycolide (PLGA) nails (Activa IM-Nail™, Bioretec Ltd., Finland) were used in 19 and titanium nails (TEN®, SynthesDePuy Ltd., USA) in 16 patients. Rotational ROM of forearm after two years was the primary outcome. Elbow and wrist ROM, pain and radiographic bone healing were secondary outcomes. Forearm rotation was mean 162° and 151° in BIN and ESIN groups, respectively (P = 0.201). No difference between the groups was found in any other ROMs. Three cases in the ESIN vs. none in the BIN group reported pain (P = 0.113). There was no clinically significant residual angulation in radiographs. Two adolescents in the BIN group vs. none in the ESIN (P = 0.245) were excluded because of implant failure; another two with complete bone union suffered from re-injury. Therefore, satisfactory implant stability among older children needs to be studied.

RCT Entities:   Population Interventions Outcomes