{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T22:18:17Z","timestamp":1778883497341,"version":"3.51.4"},"reference-count":25,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2022,5,20]],"date-time":"2022-05-20T00:00:00Z","timestamp":1653004800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Bioretec Oy"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Children"],"abstract":"<jats:p>(1) Background: Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing (ESIN) is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is performed in many patients. Often, the primary minimal invasive incision needs to be widened during implant removal. In order to decrease the burden of care of pediatric fractures, significant efforts were made to develop biodegradable implants, which make hardware removal unnecessary. Our study will conduct an observational trial on the clinical use of the Activa IM-Nail\u2122 in forearm fractures in children between 3 and 13 years of age. The objective of this trial is to evaluate the risks and benefits of the Activa IM-Nail\u2122. Among other objectives, the rate of refracture will be determined. (2) Methods: An international Europe-based, multicenter, prospective, single-arm, open-label study will be performed to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail\u2122 for patients, parents and other caregivers. The study will include clinical follow-up including early post-operative complication, radiographs until bony healing and an additional follow-up after 1 year. At this stage, preliminary results and early complications on 76 patients are analyzed in this study and presented. (3) Results: As of April 2022, 76 patients were enrolled as per study protocol. There were 31 girls (40.8%) and 45 boys (59.2%). The mean age at the time of inclusion was 8.9 years (\u00b12.4 years). The mean operation time was 58.9 \u00b1 22.9 min (range, 15\u2013119 min). The mean follow-up time was 8.9 \u00b1 5.1 months (range, 0.2\u201318.6). Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery (1\/76; 1.3%). (4) Conclusion: The research project assesses the safety and effectiveness of Activa IM-Nails\u2122 as part of the surgical treatment of dislocated forearm fractures in children in the context of a PMCF study. The use of Activa IM-Nails\u2122 with regard to various objectives, including postoperative complications and refracture rate, seems to be equal to the standard titan ESIN procedure compared to the literature. Preliminary results are encouraging and are made available.<\/jats:p>","DOI":"10.3390\/children9050754","type":"journal-article","created":{"date-parts":[[2022,5,20]],"date-time":"2022-05-20T13:56:12Z","timestamp":1653054972000},"page":"754","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children"],"prefix":"10.3390","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9959-2418","authenticated-orcid":false,"given":"Christoph","family":"Roeder","sequence":"first","affiliation":[{"name":"Department for Health Sciences, Medicine and Research, Danube University Krems, 3500 Krems, Austria"},{"name":"Department of Orthopedics and Trauma Surgery, Landesklinikum Baden\/Moedling, 2340 Moedling, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1054-4832","authenticated-orcid":false,"given":"Cristina","family":"Alves","sequence":"additional","affiliation":[{"name":"Department of Pediatric Orthopaedics, Hospital Pedi\u00e1trico de Coimbra, 3000-602 Coimbra, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3884-3804","authenticated-orcid":false,"given":"Andreas","family":"Balslev-Clausen","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Hvidovre Hospital, 2650 Hvidovre, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6114-5372","authenticated-orcid":false,"given":"Federico","family":"Canavese","sequence":"additional","affiliation":[{"name":"Department of Pediatric Orthopedic Surgery, Jeanne de Flandre Hospital, 59000 Lille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erol","family":"Gercek","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery, Helios University Hospital Wuppertal, 42283 Wuppertal, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tam\u00e1s","family":"Kassai","sequence":"additional","affiliation":[{"name":"Department of Pediatric Trauma Surgery, Dr. Manninger Jen\u0151 Baleseti K\u00f6zpont, 1081 Budapest, Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Klestil","sequence":"additional","affiliation":[{"name":"Department for Health Sciences, Medicine and Research, Danube University Krems, 3500 Krems, Austria"},{"name":"Department of Orthopedics and Trauma Surgery, Landesklinikum Baden\/Moedling, 2340 Moedling, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louise","family":"Klingenberg","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Hvidovre Hospital, 2650 Hvidovre, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1690-4162","authenticated-orcid":false,"given":"Nicolas","family":"Lutz","sequence":"additional","affiliation":[{"name":"Service de Chirurgie de l\u2019enfant et de l\u2019adolescent, Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1293-9918","authenticated-orcid":false,"given":"Marcell","family":"Varga","sequence":"additional","affiliation":[{"name":"Department of Pediatric Trauma Surgery, Dr. Manninger Jen\u0151 Baleseti K\u00f6zpont, 1081 Budapest, Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gergo","family":"Jozsa","sequence":"additional","affiliation":[{"name":"Medical Centre, Department of Paediatrics, Division of Paediatric Surgery, Traumatology, Urology and Paediatric Otolaryngology, UP Clinical Centre, 7623 P\u00e9cs, Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0385-4346","authenticated-orcid":false,"given":"Annelie","family":"Weinberg","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma, Medical University of Graz, 8036 Graz, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7997-6396","authenticated-orcid":false,"given":"Ludger","family":"T\u00fcshaus","sequence":"additional","affiliation":[{"name":"Department of Pediatric Surgery, University Medical Center Schleswig-Holstein, Campus L\u00fcbeck, 23538 L\u00fcbeck, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,5,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"701","DOI":"10.1097\/BPO.0b013e3181875b60","article-title":"Evidence-Based Analysis of Removal of Orthopaedic Implants in the Pediatric Population","volume":"28","author":"Raney","year":"2008","journal-title":"J. Pediatric Orthop."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"270","DOI":"10.1016\/j.jcot.2017.06.020","article-title":"Inpatient orthopaedic hardware removal in children: A cross-Sectional study","volume":"8","author":"Boulos","year":"2017","journal-title":"J. Clin. Orthop. Trauma"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"113","DOI":"10.5435\/00124635-200602000-00006","article-title":"Hardware Removal: Indications and Expectations","volume":"14","author":"Busam","year":"2006","journal-title":"J. Am. Acad. Orthop. Surg."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"833","DOI":"10.3390\/ma2030833","article-title":"Biodegradable Polymers in Bone Tissue Engineering","volume":"2","author":"Kroeze","year":"2009","journal-title":"Materials"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"965","DOI":"10.1302\/0301-620X.73B6.1659570","article-title":"Biodegradable pin fixation of elbow fractures in children. A randomised trial","volume":"73","author":"Hope","year":"1991","journal-title":"J. Bone Jt. Surg. Br. Vol."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Comino-Garayoa, R., Cort\u00e9s-Bret\u00f3n Brinkmann, J., Pel\u00e1ez, J., L\u00f3pez-Su\u00e1rez, C., Mart\u00ednez-Gonz\u00e1lez, J.M., and Su\u00e1rez, M.J. (2020). Allergies to Titanium Dental Implants: What Do We Really Know about Them? A Scoping Review. Biology, 9, Available online: https:\/\/www.mdpi.com\/2079-7737\/9\/11\/404.","DOI":"10.3390\/biology9110404"},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Lieber, J., Dietzel, M., Scherer, S., Sch\u00e4fer, J., Kirschner, H., and Fuchs, J. (2021). Implant removal associated complications after ESIN osteosynthesis in pediatric fractures. Eur. J. Trauma Emerg. Surg., 1\u20138.","DOI":"10.1007\/s00068-021-01763-4"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1097\/01.bpo.0000187988.86892.a2","article-title":"Pediatric Olecranon Fractures","volume":"26","author":"Gortzak","year":"2006","journal-title":"J. Pediatric Orthop."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"646","DOI":"10.1097\/01241398-199209000-00016","article-title":"Totally absorbable screws in fixation of subtalar extra articular arthrodesis in children with spastic neuromuscular disease: Preliminary report of a randomized prospective study of fourteen arthrodeses fixed with absorbable or metallic screws","volume":"12","author":"Partio","year":"1992","journal-title":"J. Pediatric Orthop."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1177\/1457496913490459","article-title":"A new mini-invasive technique in treating pediatric diaphyseal forearm fractures by bioabsorbable elastic stable intramedullary nailing: A preliminary technical report","volume":"102","author":"Sinikumpu","year":"2013","journal-title":"Scand. J. Surg."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1016\/j.biomaterials.2018.09.011","article-title":"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","volume":"185","author":"Korhonen","year":"2018","journal-title":"Biomaterials"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"221","DOI":"10.1097\/BPB.0000000000000041","article-title":"Refractures following removal of plates and elastic nails from paediatric forearms","volume":"23","author":"Makki","year":"2014","journal-title":"J. Pediatric Orthop. B"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1097\/BPB.0000000000000408","article-title":"Elastic stable intramedullary nailing in paediatric forearm fractures: The rate of open reduction and complications","volume":"26","author":"Makki","year":"2017","journal-title":"J. Pediatric Orthop. B"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1097\/BPO.0b013e3182a11d3b","article-title":"Complications and Outcomes of Diaphyseal Forearm Fracture Intramedullary Nailing","volume":"33","author":"Martus","year":"2013","journal-title":"J. Pediatric Orthop."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e6669","DOI":"10.1097\/MD.0000000000006669","article-title":"Low complication rate of elastic stable intramedullary nailing (ESIN) of pediatric forearm fractures","volume":"96","author":"Kruppa","year":"2017","journal-title":"Medicine"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1097\/BPB.0000000000000635","article-title":"Surgical treatment of pediatric forearm fractures with intramedullary nails: Is it a disadvantage to leave the tip exposed?","volume":"29","author":"Topal","year":"2020","journal-title":"J. Pediatric Orthop. B"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1007\/s11832-010-0245-y","article-title":"Failures and complications in intramedullary nailing of children\u2019s forearm fractures","volume":"4","author":"Fernandez","year":"2010","journal-title":"J. Child. Orthop."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"101","DOI":"10.4055\/cios.2017.9.1.101","article-title":"Flexible intramedullary nailing of forearm fractures at the distal metadiaphyseal junction in adolescents","volume":"9","author":"Kim","year":"2017","journal-title":"CiOS Clin. Orthop. Surg."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"482","DOI":"10.1097\/BPB.0b013e3283528db5","article-title":"Titanium elastic nailing radius and ulna fractures in adolescents","volume":"21","author":"Wall","year":"2012","journal-title":"J. Pediatric Orthop. B"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"S11","DOI":"10.1016\/S0020-1383(13)70190-6","article-title":"Treatment outcomes of both-bone diaphyseal paediatric forearm fractures","volume":"44","author":"Antabak","year":"2013","journal-title":"Injury"},{"key":"ref_21","first-page":"415","article-title":"ESIN and K-wire fixation has similar results in both bone pediatric forearm fractures","volume":"23","author":"Sahin","year":"2017","journal-title":"Turk. J. Trauma Emerg. Surg."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"749","DOI":"10.1097\/BPO.0000000000000210","article-title":"Exposed Versus Buried Intramedullary Implants for Pediatric Forearm Fractures","volume":"34","author":"Kelly","year":"2014","journal-title":"J. Pediatric Orthop."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"827","DOI":"10.1097\/01.bpo.0000235397.64783.d6","article-title":"Use and Abuse of Flexible Intramedullary Nailing in Children and Adolescents","volume":"26","author":"Lascombes","year":"2006","journal-title":"J. Pediatric Orthop."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1007\/s00590-015-1715-1","article-title":"Risk factors for re-fracture in children with diaphyseal fracture of the forearm treated with elastic stable intramedullary nailing","volume":"26","author":"Rousset","year":"2016","journal-title":"Eur. J. Orthop. Surg. Traumatol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"414","DOI":"10.1016\/j.injury.2008.10.022","article-title":"Paediatric diaphyseal forearm refractures after greenstick fractures: Operative management with ESIN","volume":"40","author":"Amerstorfer","year":"2009","journal-title":"Injury"}],"container-title":["Children"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2227-9067\/9\/5\/754\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T23:15:32Z","timestamp":1760138132000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2227-9067\/9\/5\/754"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,20]]},"references-count":25,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2022,5]]}},"alternative-id":["children9050754"],"URL":"https:\/\/doi.org\/10.3390\/children9050754","relation":{},"ISSN":["2227-9067"],"issn-type":[{"value":"2227-9067","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,20]]}}}