Murat Calbiyik1, Deniz Ipek2, Mehmet Taskoparan3. 1. Department of Orthopaedics, Hitit University Corum Education and Research Hospital, Corum, Turkey. muratcalbiyik19@gmail.com. 2. Department of Orthopaedics, Hitit University Corum Education and Research Hospital, Corum, Turkey. 3. Department of Orthopaedics, Private Eskisehir Sakarya Hospital, Eskisehir, Turkey.
Abstract
PURPOSE: To reveal whether minimal invasive implantation of a novel intramedullary device produces comparable outcomes with LCP fixation in patients with displaced midshaft clavicle fractures. METHODS: A prospective randomized two-arm study was performed on patients presenting with Robinson type 2B1 and 2B2 displaced midshaft clavicle fractures with >2 cm shortening. In group 1 (n = 35, mean age; 42.02 ± 13.87) patients received minimal invasive intramedullary fixation with Sonoma Crx device (Sonoma, USA) whereas in group 2 (n = 40, mean age; 39.07 ± 7.04) patients received 3.5 mm locking compression plate (Synthes, USA). Functional assessment was made using range of motion measurement (ROM), constant shoulder score and DASH disability of the arm, shoulder and hand (DASH) scoring. RESULTS:Mean time of operation was similar between the two groups (p = 0.46) whereas mean time of fluoroscopy was significantly longer in group 1 compared to group 2 (p < 0.001). At the 12 month follow-up, there was a slight but significant difference in ROM degrees between the two groups (p = 0.005). Mean quick DASH score was significantly lower in group 1 than that in group 2 (p < 0.001) whereas there was no significant difference in constant shoulder scores between the two groups (p = 0.06). Time to bony union was also shorter in group 1 compared to group 2 (p < 0.001). CONCLUSION:Minimal invasive intramedullary implantation technique provided satisfactory clinical outcomes and shortened the time until bony union compared to LCP fixation. Further study on larger populations is required to establish whether the technique offers lower complication rates than LCP fixation.
RCT Entities:
PURPOSE: To reveal whether minimal invasive implantation of a novel intramedullary device produces comparable outcomes with LCP fixation in patients with displaced midshaft clavicle fractures. METHODS: A prospective randomized two-arm study was performed on patients presenting with Robinson type 2B1 and 2B2 displaced midshaft clavicle fractures with >2 cm shortening. In group 1 (n = 35, mean age; 42.02 ± 13.87) patients received minimal invasive intramedullary fixation with Sonoma Crx device (Sonoma, USA) whereas in group 2 (n = 40, mean age; 39.07 ± 7.04) patients received 3.5 mm locking compression plate (Synthes, USA). Functional assessment was made using range of motion measurement (ROM), constant shoulder score and DASH disability of the arm, shoulder and hand (DASH) scoring. RESULTS: Mean time of operation was similar between the two groups (p = 0.46) whereas mean time of fluoroscopy was significantly longer in group 1 compared to group 2 (p < 0.001). At the 12 month follow-up, there was a slight but significant difference in ROM degrees between the two groups (p = 0.005). Mean quick DASH score was significantly lower in group 1 than that in group 2 (p < 0.001) whereas there was no significant difference in constant shoulder scores between the two groups (p = 0.06). Time to bony union was also shorter in group 1 compared to group 2 (p < 0.001). CONCLUSION: Minimal invasive intramedullary implantation technique provided satisfactory clinical outcomes and shortened the time until bony union compared to LCP fixation. Further study on larger populations is required to establish whether the technique offers lower complication rates than LCP fixation.
Authors: Frans-Jasper G Wijdicks; R M Houwert; Peter J Millett; Egbert J J M Verleisdonk; Olivier A J Van der Meijden Journal: Can J Surg Date: 2013-02 Impact factor: 2.089
Authors: Federico Canavese; Lorenza Marengo; Alexandru Tiris; Mounira Mansour; Marie Rousset; Antoine Samba; Antonio Andreacchio; Alain Dimeglio Journal: Int Orthop Date: 2017-03-22 Impact factor: 3.075
Authors: Christopher Vannabouathong; Justin Chiu; Rahil Patel; Shreyas Sreeraman; Elias Mohamed; Mohit Bhandari; Kenneth Koval; Michael D McKee Journal: JSES Int Date: 2020-05-04