Öz
Objective: The aim of this study was to compare early results and implant-related complication rates of CE certified locally manufactured orthopedic implants, and overseas manufactured systems with proven efficacy and reliability via clinical studies in the surgical fixation of forearm fractures.
Material and Methods: Patients diagnosed with fractures of radius lower end and shaft, ulna shaft and double forearm and treated by open reduction + plate and screw fixation between January 1, 2013 and December 31, 2018 were analyzed retrospectively. Between January 2013 and December 2016, the overseas manufactured plate systems and between December 2016 and December 2018, the locally manufactured plate systems were used. Patients were grouped according to the fracture location and plate systems as Group A (radius lower end fracture), Group B (radius shaft, ulna shaft, and double forearm), and Groups A-1/B-1 (oversea-manufactured) and Groups A-2/B-2 (local-manufactured). Patients were evaluated in terms of implant-related and non-implant-related complications within the first postoperative year.
Results: There were 88 (46 men, 42 women) and 53 patients (15 men, 38 women) in Group A and Group B respectively. While the median age of the patients in Group A was 48 years, this value was 19 years in Group B (p<0.001). There were significantly more male patients in Group B than Group A (p=0.036). Group A had six implant-related and 12 non-implant-related complications. Implant-related complication rates in Group A-1 and Group A-2 were 6.7% and 7%. There were no implant-related complications in Group B. Non-implant complications were detected in two patients.
Conclusion: The rates of early implant-related complications were similar in those of locally manufactured plate systems certified with CE certificate and the overseas manufactured counterparts certified by FDA and CE certificates in the surgical fixation of radial lower end fractures and radius and / or ulna shaft fractures.