Abstract
BackgroundIn the modern western world appraisal of economical points such as treatment and disability after trauma present a financial burden. In this context open reduction internal fixation techniques allowing for early full weight bearing might not only improve the clinical outcome but also shorten the period of disability in working life. The aim of the study was to analyze whether ORIF of ankle fractures using either a standard semitubular plate or a new polyaxial locking plate system result in a better clinical outcome.MethodsIn this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score, Foot and Ankle outcome score and Karlsson and Peterson Scoring System for Ankle function. Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.ResultsFifty-two patients (31 W/21 M) with a mean age of 43 yrs. (range 22–64 yrs.) were enrolled. Seven patients (13.5%) were excluded, so that 45 patients were available for follow up. Twenty-five patients were treated with DePuy Synthes® one-third semitubular plate (55.6%; group I) while 20 patients received an anatomically preformed polyaxial locking plate (44.4%, group II). Four minor complications occurred in Group I (16%) compared to two minor complications in group II (10%). Significant better clinical results regarding OMAS (p < 0.02, < 0.04), KPSS (p < 0.04) and FAOS (p < 0.02, < 0.03) were observed 6 and 12 weeks after surgery in group II.ConclusionsThe results of the presented study demonstrate a significant better clinical functional outcome in the early postoperative follow-up in patients treated with a polyaxial locking plate. Furthermore, our data show that ORIF using polyaxial locking plates in combination with an early postoperative weight bearing presents a safe, stable treatment option for ankle fractures so that patients benefit especially in the early stages of recovery.Trial registrationRegistered 20 April 2020, retrospectively on ClinicalTrails.gov (NCT04370561).
Highlights
In the modern western world appraisal of economical points such as treatment and disability after trauma present a financial burden
Operative treatment is associated with typical complications such as non- or malunion, post-traumatic arthritis and especially soft tissue problems ranging from delayed wound healing to deep infection and severe soft tissue defects [11,12,13,14,15]
45 of 52 patients (86.5%) were available for all follow up examinations, and enrolled had a mean age of 42 years at the time of injury with no statistical difference between both groups
Summary
In the modern western world appraisal of economical points such as treatment and disability after trauma present a financial burden In this context open reduction internal fixation techniques allowing for early full weight bearing might improve the clinical outcome and shorten the period of disability in working life. In the current literature multiple studies compare conservative and surgical treatment in malleolar FX [2,3,4] In this context open reduction and internal fixation (ORIF) presents the standard of care for displaced ankle FX in adults [4,5,6]. Besides fracture healing especially postoperative joint rehabilitation determines functional outcome and thereby return to sports, work and normal daily activities. In the past a few clinical trials revealed that early weightbearing and functional treatment avoiding a plaster cast may shorten the immobilization period but may provoke a loss of reduction depending on morphology, initial stability of the FX as well as on patient’s age and comorbidities [19,20,21,22,23,24]
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