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Stryker t2 alpha pdf4/26/2023 ![]() Intramedullary (IM) nailing-the insertion of a surgical nail along the medullary cavity-is commonly used to stabilise these fractures as it enables stable fixation with minimal soft-tissue damage. Tibial shaft fractures are the most common long bone fracture. ![]() This trial was prospectively registered on the 7 February 2020 on ANZCTR, ACTRN12620000109909. Limitations of the study include an unpredictable enrolment rate and loss to follow-up, small sample size, and the unknown ability of three-dimensional motion analysis to pick up the effects of anterior knee pain after tibial nailing. Evaluation of all clinical data and patient outcomes will lead to the development of a new tool for assessing patient outcomes in this cohort. This study will establish the feasibility and inform the design of a large-scale RCT. The primary clinical outcome is the incidence of anterior knee pain at 12 months after surgery. Feasibility outcomes include ability to meet enrolment and retention metrics, compliance with all questionnaires and assessment procedures, and the occurrence of any adverse events. Follow-up time points are 3, 6, 12, and 18 months. Performance-based outcome measures will be assessed utilising three-dimensional motion capture techniques. Patients will undergo standard radiograph, magnetic resonance imaging, and clinical assessments in-line with their standard operative care, and complete a number of patient-reported and performance-based outcome measures. All nails in this study will be Stryker T2 Alpha nails. This study aims to recruit 60 patients between 18 and 60 years old who will be randomly assigned to either the suprapatellar or infrapatellar approach following a decision for intramedullary surgical fixation by the treating surgeon. This pilot study will follow a prospective randomised controlled design at the Royal Adelaide Hospital and The Queen Elizabeth Hospital (South Australia). The central aims of this study are to (1) evaluate the feasibility of a full-scale randomised controlled trial (RCT) investigating the influence of surgical approach on intramedullary nailing of tibial shaft fractures (suprapatellar versus infrapatellar nailing), (2) explore differences in clinical outcomes between the approaches, and (3) explore the development of a biomechanically validated methodology for assessing post-operative anterior knee pain and knee function specific to intramedullary nailing of tibial shaft fractures. To date, no biomechanically validated method exists to assess patient outcomes specific to anterior knee pain in this cohort. The aetiology remains unclear, but the surgical approach may play an important role. Anterior knee pain is often reported following intramedullary nailing of tibial shaft fractures.
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