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

Abstract

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. Trial registration This trial was prospectively registered on the 7 February 2020 on ANZCTR, ACTRN12620000109909.

The absence of reporting standards and a lack of objective, performance-based outcomes following intramedullary nailing of tibial shaft fractures: findings from a scoping review into 179 articles

“…Of the 44/152 (29%) studies reporting AKP, only 10/44 (23%) studies reported an accompanying VAS or NRS score (8 and 2 studies, respectively). The use of binary measures alone is problematic as they are unable to distinguish differing degrees of pain, or pain only with certain activities; require large participant numbers for adequate study power [ 41 ]; and are limited in their ability to detect differences between treatments [ 42 ]. Conversely, continuous scales provide a more clinically informative statistic: they enable the calculation of the proportion of patients who achieve a clinically important improvement in pain scores [ 43 ].…”

Effect of individualized narrative nursing mode on recovery of elderly patients with fracture complicated with cerebrovascular accident

“…The patients' self-cognition and improve patients' cognitive ability will be reshaped. [40][41][42] Eventually, patients should be guided to find that life not only has immediate difficulties but also unlimited possibilities in the future, change patients' attitude toward life, and greet future life with more enthusiasm. [43,44] The main limitation of this study is that the sample size of the study is small and the follow-up time is short.…”

Ventajas y desventajas del uso de clavo de tibia suprapatelar e infrapatelar en fracturas de tibia.

“…Por un lado, el procedimiento puede conducir al desplazamiento proximal del fragmento de fractura con la rodilla en flexión, lo que, en consecuencia, genera valgus y procurvatum, además, se genera inflamación en la extremidad, aumentando el riesgo de síndrome compartimental y alarga la duración quirúrgica [1,5]. Por su parte, es preciso señalar que el dolor postoperatorio en la parte anterior de la rodilla es la complicación más frecuente tras el enclavado tibial, y reporta una incidencia que varía del 10 al 86% de los pacientes [2,[6][7].…”