Intramedullary nailing versus external ring fixator for treatment of tibial fractures – a study protocol for a randomised clinical trial

TY - JOUR

T1 - Intramedullary nailing versus external ring fixator for treatment of tibial fractures – a study protocol for a randomised clinical trial

AU - Stokholm, Rasmus

AU - Larsen, Peter

AU - Rölfing, Jan Duedal

AU - Petruskevicius, Juozas

AU - Rasmussen, Morten Kjerri

AU - Skov, Steffen

AU - Elsøe, Rasmus

PY - 2023/12/6

Y1 - 2023/12/6

N2 - 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.

AB - 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.

KW - Adult

KW - Humans

KW - Quality of Life

KW - Fracture Fixation, Intramedullary/methods

KW - Prospective Studies

KW - Activities of Daily Living

KW - Tibial Fractures/surgery

KW - Pain

KW - Treatment Outcome

KW - Randomized Controlled Trials as Topic

KW - Multicenter Studies as Topic

UR - http://www.scopus.com/inward/record.url?scp=85182954487&partnerID=8YFLogxK

M3 - Journal article

C2 - 38235983

SN - 2245-1919

VL - 71

JO - Danish Medical Journal

JF - Danish Medical Journal

IS - 1

M1 - A05230281

ER -