Linda Korhonen, Marja Perhomaa, Antti Kyrö, Tytti Pokka, Willy Serlo, Juhani Merikanto, Juha-Jaakko Sinikumpu, 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, Biomaterials, Volume 185, 2018, Pages 383-392, ISSN 0142-9612, https://doi.org/10.1016/j.biomaterials.2018.09.011
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
|Author:||Korhonen, Linda1; Perhomaa, Marja2; Kyrö, Antti3;|
1Department of Children and Adolescents, Pediatric Surgery and Orthopedics, Medical Research Centre Oulu and PEDEGO Research Group, Oulu University, Oulu, Finland
2Department of Radiology, Pediatric Radiology, Oulu University Hospital, Finland
3Department of Orthopedics, Päijät-Häme Central Hospital, Lahti, Finland
|Online Access:||PDF Full Text (PDF, 2.5 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2019060719551
|Publish Date:|| 2020-09-11
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.
|Pages:||383 - 392|
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
3123 Gynaecology and paediatrics
We are thankful to Mrs. Anna-Maija Haltia, M.Sc., and Mrs. Minna Veiranto, M.Sc., employed by Bioretec Ltd. Finland, that provided the implants for this study. We also thank The Finnish Paediatric Orthopaedics Society, the Vaasa Foundation of Physicians, The Finnish Society of Paediatric Surgeons, The Finnish Foundation of Paediatric Research and The Alma and K. A. Snellman Foundation for supporting the study.
© 2018. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/.