Investigating and defining outcomes of suprapatellar versus infrapatellar intramedullary nailing of tibial shaft fractures: a protocol for a pilot randomised controlled trial

Background: Anterior knee pain is often reported following intramedullary nailing of tibial shaft fractures. The aetiology remains unclear, but the surgical approach may play an important role. To date, no biomechanically validated method exists to assess patient outcomes specific to anterior knee pain in this cohort. 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. Methods: This pilot study will follow a prospective randomised controlled design at the Royal Adelaide Hospital and The Queen Elizabeth Hospital (South Australia). 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. All nails in this study will be Stryker T2 Alpha nails. 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. Performance-based outcome measures will be assessed utilising three-dimensional motion capture techniques. Follow-up time points are 3, 6, 12, and 18 months. Feasibility outcomes include ability to meet enrolment and retention metrics, compliance with all questionnaires and assessment procedures, and the occurrence of any adverse events. The primary clinical outcome is the incidence of anterior knee pain at 12 months after surgery. Discussion: This study will establish the feasibility and inform the design of a large-scale RCT. Evaluation of all clinical data and patient outcomes will lead to the development of a new tool for assessing patient outcomes in this cohort. 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.