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.
Subject(s)
Fractures, Bone , Quality of Life , Arthrodesis , Cost-Benefit Analysis , Fracture Fixation, Internal , Humans , Multicenter Studies as Topic , Prospective Studies , Randomized Controlled Trials as Topic , Review Literature as Topic , Treatment OutcomeABSTRACT
The aim of this study was to quantify the stability of fracture-implant complex in fractures after fixation. A total of 15 patients with an undisplaced fracture of the femoral neck, treated with either a dynamic hip screw or three cannulated hip screws, and 16 patients with an AO31-A2 trochanteric fracture treated with a dynamic hip screw or a Gamma Nail, were included. Radiostereometric analysis was used at six weeks, four months and 12 months post-operatively to evaluate shortening and rotation. Migration could be assessed in ten patients with a fracture of the femoral neck and seven with a trochanteric fracture. By four months post-operatively, a mean shortening of 5.4 mm (-0.04 to 16.1) had occurred in the fracture of the femoral neck group and 5.0 mm (-0.13 to 12.9) in the trochanteric fracture group. A wide range of rotation occurred in both types of fracture. Right-sided trochanteric fractures seem more rotationally stable than left-sided fractures. This prospective study shows that migration at the fracture site occurs continuously during the first four post-operative months, after which stabilisation occurs. This information may allow the early recognition of patients at risk of failure of fixation.
