Weight-bearing or non-weight-bearing after surgical treatment of ankle fractures: a multicenter randomized controlled trial.

PURPOSE: The goal of this study was to assess if unprotected weight-bearing as tolerated is superior to protected weight-bearing and unprotected non-weight-bearing in terms of functional outcome and complications after surgical fixation of Lauge-Hansen supination external rotation stage 2-4 ankle fractures. METHODS: A multicentered randomized controlled trial was conducted in patients ranging from 18 to 65 years of age without severe comorbidities. Patients were randomized to unprotected non-weight-bearing, protected weight-bearing, and unprotected weight-bearing as tolerated. The primary endpoint of the study was the Olerud Molander Ankle Score (OMAS) 12 weeks after randomization. The secondary endpoints were health-related quality of life using the SF-36v2, time to return to work, time to return to sports, and the number of complications. RESULTS: The trial was terminated early as advised by the Data and Safety Monitoring Board after interim analysis. A total of 115 patients were randomized. The O'Brien-Fleming threshold for statistical significance for this interim analysis was 0.008 at 12 weeks. The OMAS was higher in the unprotected weight-bearing group after 6 weeks c(61.2 ± 19.0) compared to the protected weight-bearing (51.8 ± 20.4) and unprotected non-weight-bearing groups (45.8 ± 22.4) (p = 0.011). All other follow-up time points did not show significant differences between the groups. Unprotected weight-bearing showed a significant earlier return to work (p = 0.028) and earlier return to sports (p = 0.005). There were no differences in the quality of life scores or number of complications. CONCLUSIONS: Unprotected weight-bearing and mobilization as tolerated as postoperative care regimen improved short-term functional outcomes and led to earlier return to work and sports, yet did not result in an increase of complications.

Ankle Fracture Classification: An Innovative System for Describing Ankle Fractures.

A good classification system is important for clinical handoffs, research, and clinical treatment guidelines. A reliable classification system shows good interobserver and intraobserver agreement. This study analyzed the interobserver and intraobserver agreement of a descriptive system for ankle fractures and the Lauge-Hansen classification. Three groups of observers (experts, semiexperts, and novices) scored a total of 20 ankle radiographs. All ankle radiographs were classified according to the Lauge-Hansen and Danis-Weber classifications. The ankle fractures were subsequently reviewed in a descriptive manner for the following features: number of affected malleoli, type of fracture of the lateral and medial malleolus, and congruence of the ankle joint. After 2 weeks, the same set of radiographs were reviewed. For interobserver and intraobserver variability, the separate groups were used for analysis, and the Fleiss (multirater) κ values were calculated. The interobserver agreement for the Lauge-Hansen classification was moderate for the experts, fair for semiexperts, and slight for novices (κ = 0.45, κ = 0.37, and κ = 0.16). All factors of the descriptive system had better interobserver agreement than the Lauge-Hansen classification, except for the agreement on the type of fracture of the lateral malleolus. The intraobserver agreement of the Lauge-Hansen classification was substantial for the experts, moderate for the semiexperts, and fair for the novice observers (κ = 0.70, κ = 0.49, and κ = 0.26). The intraobserver agreement was better for all factors of the descriptive system compared with the Lauge-Hansen classification. The descriptive system presented in this study shows less variability between observers than the Lauge-Hansen classification. This system has clinical implications and is easy to use for clinicians with mixed levels of experience. It has the potential to improve clinical and research handoffs and overcome the limitations of current classification systems.

Differences in Classification Between Mono- and Polytrauma and Low- and High-Energy Trauma Patients With an Ankle Fracture: A Retrospective Cohort Study.

Although fracture type and treatment options for ankle fractures are well defined, the differences between mono- and polytrauma patients and low- and high-energy trauma have not been addressed. The aim of the present study was to compare the fracture type and trauma mechanism between mono- and polytrauma and low- and high-energy trauma patients with an ankle fracture. We performed a single-center retrospective cohort study. Fractures were classified according to the Lauge-Hansen classification and a descriptive classification. High-energy trauma (HET) was defined using triage criteria. All other patients were classified as having experienced low-energy trauma (LET). The patients were divided into 2 groups according to the injury severity score (ISS). Monotrauma patients were defined as patients with an ISS of 4 to 11 with an isolated ankle fracture or an ankle fracture with a minor contusion or laceration. Polytrauma patients were defined as patients with an ISS of ≥16 with ≥2 body regions involved. Patients with an ISS from 12 to 15 were excluded. A total of 96 patients were eligible for analysis. Of the 96 patients, 62 had experienced monotrauma and 34 had experienced polytrauma. A significant difference was found between the mono- and polytrauma patients in the Lauge-Hansen classification (p < .001). Monotrauma patients had a high incidence of an isolated supination external rotation injury. Supination adduction and pronation abduction injuries were more often observed in polytrauma patients. The same pattern was observed for ankle fractures after HET compared with LET (p < .001), because all pronation abduction and supination adduction injuries were observed after a HET mechanism. The results of the present study indicate that polytrauma patients sustain different types of ankle fractures than patients with an isolated ankle fracture. This difference likely results from the high-energy transfer associated with polytrauma, because pronation abduction and supination adduction injuries were only observed after HET.

Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: study protocol for a randomized controlled trial.

BACKGROUND: The optimal post-operative care regimen after surgically fixed Lauge Hansen supination exorotation injuries remains to be established. This study compares whether unprotected weight bearing as tolerated is superior to protected weight bearing and unprotected non-weight bearing in terms of functional outcome and safety. METHODS/DESIGN: The WOW! Study is a prospective multicenter clinical trial. Patients between 18 and 65 years of age with a Lauge Hansen supination exorotation type 2, 3 or 4 ankle fractures requiring surgical treatment are eligible for inclusion. An expert panel validates the classification and inclusion eligibility. After surgery, patients are randomized to either the 1) unprotected non-weight-bearing, 2) protected weight-bearing, or 3) unprotected weight-bearing group. The primary outcome measure is ankle-specific disability measured by the Olerud-Molander ankle score. Secondary outcomes are 1) quality of life (e.g., return to work and resumption of sport), 2) complications, 3) range of motion, 4) calf wasting, and 5) maximum pressure load after 3 months and 1 year. DISCUSSION: This trial is designed to compare the effectiveness and safety of unprotected weight bearing with two commonly used post-operative treatment regimens after internal fixation of specified, intrinsically stable but displaced ankle fractures. An expert panel has been established to evaluate every potential subject, which ensures that every patient is strictly screened according to the inclusion and exclusion criteria and that there is a clear indication for surgical fixation. TRIAL REGISTRATION: The WOW! Study is registered in the Dutch Trial Register ( NTR3727 ). Date of registration: 28-11-2012.