RESUMEN
INTRODUCTION: Tibial shaft fractures are among the most common lower extremity fractures. Treatment of tibial shaft fractures with intramedullary nailing has become the treatment of choice in adults. However, commonly reported outcomes include knee pain, limitations in activities of daily living and reduction in quality of life (QOL). The literature lacks high-quality studies to document superiority of intramedullary nailing versus other surgical treatment methods. The present study aims to compare the 12-month Knee Injury and Osteoarthritis Outcome Score (KOOS) - sport and recreation activities (sport/rec) after standard intramedullary nailing with external ring fixation for adult patients with isolated tibial shaft fractures. METHODS: This study is a multicentre randomised, prospective clinical trial. A total of 67 patients will be included in the study, and the primary outcome will be the KOOS-sport/rec at 12 months after surgery. CONCLUSIONS: With KOOS-sport/rec as the primary outcome, the findings of the present study are expected to advance our understanding of knee pain, function and QOL, regardless of the treatment option and the outcome of the study. FUNDING: The project is partially funded by the Independent Research Found Denmark. CLINICALTRIALS: gov ID: NCT-03945669, version 1.1, 21 September 2022.
Asunto(s)
Fijación Intramedular de Fracturas , Fracturas de la Tibia , Adulto , Humanos , Calidad de Vida , Fijación Intramedular de Fracturas/métodos , Estudios Prospectivos , Actividades Cotidianas , Fracturas de la Tibia/cirugía , Dolor , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
INTRODUCTION: Although a large number of previous studies have investigated the outcome in patients following tibial shaft fractures, the literature provides limited information on prospectively reported patients with mid- to long-term follow-up. The present study aimed to investigate prospectively the 5-year development in patient-reported quality of life after intramedullary nailing of a tibial shaft fracture. MATERIAL AND METHODS: The design was a prospective, 5-year follow-up cohort study. Quality of life (QOL) was measured with the questionnaire Eq5d-5L and compared to the 1-year outcome reported by the same patients. Secondary outcome measurements were the Knee Injury and Osteoarthritis Outcome Score (KOOS), recordings of pain, gait and muscle strength. RESULTS: Twenty-nine patients were eligible for participation. Mean patient age at the time of the 5-year follow-up was 46.3 years. The 5-year postoperative mean Eq5d-5L index was 0.864 (95% CI 0.809-0.918). The mean Eq5d-5L VAS was 88.4 (95% CI 83.4-93.5). Compared with the same patients' Eq5d-5L index scores at the 1-year follow-up (0.784), a significant increase was observed (P = 0.014). A comparison to the Danish Eq.5D reference population showed no statistically significant difference. CONCLUSIONS: Patient-reported quality of life among patients treated with intramedullary nailing following a tibial shaft fracture increased significantly between the 1-year and 5-year follow-up. In contrast to the 1-year patient-reported quality of life, results are comparable to those of a reference population at the 5-year follow-up. In a clinical setting, these results highlight that patients may expect a prolonged period to recover. However, of most importance is that patients can expect a satisfactory outcome years after fracture and treatment.
