Randomized Controlled Trial of the Clinical Recovery and Biodegradation of Polylactide-co-glycolide Implants Used in the Intramedullary Nailing of Children's Forearm Shaft Fractures with at Least Four Years of Follow-Up.

Marja Perhomaa,Willy Serlo,Tytti Pokka,Jaakko Niinimäki,Linda Korhonen,Antti Kyrö,Juha-Jaakko Sinikumpu

doi:10.3390/jcm10050995

Abstract

The preferred surgical fixation of forearm shaft fractures in children is Elastic Stable Intramedullary Nailing (ESIN). Due to known disadvantageous effects of metal implants, a new surgical method using biodegradable polylactide-co-glycolide (PLGA) intramedullary nails has been developed but its long-term outcomes are unclear. The aim of this study was to compare the long-term outcomes of Biodegradable Intramedullary Nailing (BIN) to ESIN and assess the biodegradation of the study implants via magnetic resonance imaging (MRI). The study population of the prospective, randomized trial consisted of paediatric patients whose forearm shaft fractures were treated with BIN (n = 19) or ESIN (n = 16). Forearm rotation at minimally four years’ follow-up was the main outcome. There was no clinically significant difference in the recovery of the patients treated with the BIN as compared to those treated with the ESIN. More than half of the implants (57.7%, n = 15/26) were completely degraded, and the rest were degraded almost completely. The PLGA intramedullary nails used in the treatment of forearm shaft fractures in this study resulted in good function and anatomy. No unexpected disadvantages were found in the degradation of the implants. However, two implant failures had occurred in three months postoperatively.

Highlights

In traumatology, bioabsorbable implants have been used in different indications for several decades with promising outcomes [1,2,3,4,5,6,7,8,9]
Functional Results and Residual Symptoms In per protocol (PP) analysis, the pronation of the forearm, flexion of the elbow, and volar flexion of the wrist were slightly better in the Biodegradable Intramedullary Nailing (BIN) patients than the Elastic Stable Intramedullary Nailing (ESIN) patients, with the pronation being 79◦ in the BIN group versus 73◦ in the ESIN group (p = 0.030)
In this prospective randomized trial with at least four years of follow-up, we found that the long-term clinical outcomes of the study method four years of follow-up, we found that the long-term clinical outcomes of the study (BIN) were at least as good as those in the reference method (ESIN)

Summary

Introduction

Bioabsorbable implants have been used in different indications for several decades with promising outcomes [1,2,3,4,5,6,7,8,9]. The degradation rate depends on the geometry and size of the implant as well as molecular characteristics, such as the ratio of different copolymers [3]. Contrary to conventional implant materials, such as titanium alloy, biodegradable implants are not inert in the human body and foreign-body reaction is evident [2,3]. This inflammatory tissue response is in most cases clinically not important [2]. Osteolysis with biodegradable devises is considered to be the most common adverse event of these implants in orthopaedic practice [10,11]

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