Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial

Abstract

Background The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. Methods Study design: A prospective multicenter RCT. Study population: All patients of 18 years and older with an acute (< 6 weeks) traumatic fracture dislocation in the Lisfranc midfoot joints, displaced on static radiographic evaluation or unstable with dynamic evaluation, weight bearing radiographs or fluoroscopic stress testing under anesthesia, and eligible for either one of the surgical procedures. In total, this study will include n = 112 patients with Lisfranc fracture dislocation. Interventions: Patients with Lisfranc fracture dislocation will be randomly allocated to treatment in “The Better to Fix or Fuse Study” (The BFF Study) with either PA or ORIF. Main study parameters/endpoints: Primary outcome parameter: the quality of life. Secondary outcomes: complications, functional outcomes, secondary surgical interventions and cost effectiveness. Nature and extent of the burden: PA is expected to have a better outcome, however both treatments are accepted for this injury with a similar low risk of complications. Follow up is standardized and therefore this study will not add extra burden to the patient. Discussion This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic. Trial registration Current controlled Trial: NCT04519242 with registration date: 08/13/2020. Retrospectively registered; Protocol date and version: Version 4 05/06/2020

Functional Outcomes of Primary Arthrodesis (PA) Versus Open Reduction and Internal Fixation (ORIF) in the Treatment of Lisfranc Injuries

“…17 To further elucidate this area of concern, van den Boom et al is currently leading an ongoing multicenter randomized controlled trial (RCT) evaluating cost-effectiveness of PA versus ORIF for Lisfranc injuries. 18…”

Open Reduction Internal Fixation vs Primary Arthrodesis for Lisfranc Fracture-Dislocations: A Cost Analysis

“… 17 , 24 Both methods have advantages and disadvantages, though PA may be considered as the treatment of choice in pure ligamentous injuries. 23 Although previous studies have not demonstrated a significant difference, PA may demonstrate a trend towards less subsequent secondary surgery, less implant removal, and a faster return to activity, with some evidence of better functional outcomes, 5 , 7 - 9 , 11 , 13 , 16 , 18 , 21 , 24 preventing the need for secondary interventions and reducing the probability of developing posttraumatic arthritis. 5 , 9 , 13 , 20 ORIF risks development of secondary arthritis in 40% to 90% of patients and the possibility of costly secondary interventions such as removal of the osteosynthesis materials for pain relief or subsequent arthrodesis.…”

“… 10 , 15 However, preserving patency of the midfoot joints through ORIF with staged removal of hardware may improve functional mobility and thereby quality of life. 23 …”