The WOW! Study. Weight-bearing or Non-weight bearing.

Rationale:

Indications for surgical treatment of ankle fractures are well defined, controversy exists with regard to the optimal postoperative treatment. Multiple postoperative care regimes exist and have been described as successful. However, an adequately powered prospective study comparing postoperative treatments and wound related problems is still lacking.



Objective:

The main objective of this multicenter prospective study is to compare functional outcome measured by the Olerud Molander Score at 12 weeks after operative fixation of an ankle fracture with three different postoperative care regimes. To be known: A) unprotected non-weight-bearing mobilisation with active exercises, B) protected weight-bearing mobilisation with a cast or C) unrestricted weight-bearing mobilisation with active exercises.



Study design:

This study is a prospective multicenter clinical study, which will be accomplished in three level 1 trauma centers (Academic Medical Center Utrecht, St. Elisabeth Hospital Tilburg, Medisch Centrum Haaglanden) and three large level 2 trauma centers (Antonius Hospital Nieuwegein, Diakonessenhuis Utrecht, Twee Steden Hospital Tilburg). Patients will be recruited at the emergency department and registered to the study. The indication for trial participation will be validated by an expert panel, who will classify the fracture based on the initial X-rays. After assessment and licensing by this panel, informed consent will be obtained. After open reduction and internal fixation patients will be randomised by a computerized blocked randomization and stratified by the participating hospitals. Patients who are allowed weight-bearing therapy will get a pressure-chip installed to their shoe or cast to analyse the weight distribution of the operatively fixed ankle during the first 6 weeks of rehabilitation. Reviews of the patients will be accomplished by the treating surgeon or investigator after 2, 6, 12 weeks, 6 and 12 months. Each visit includes physical examination, standardized clinical evaluation, registration of possible complications and completing the Olerud Molander and SF-36 questionnaires.



Study population:

Patients from 18 to 65 years will be included with fractures classified as Lauge Hansen supination-eversion 2-4 injury with concomitant articular discongruity of more than 2 mm.



Intervention:

After operative fixation of the ankle fractures, patients will be treated by one of the three treatment protocols, depending on randomisation: A) unrestricted non-weight-bearing mobilisation with active exercises, B) protected weight-bearing mobilisation with a cast or C) unrestricted weight-bearing mobilisation with active exercises.



Main study parameters/endpoints:

The Olerud Molander ankle score is the main study parameter/endpoint (12 weeks after surgery). Grouping of secondary endpoints results in three outcome groups: 1) Patient satisfaction (Olerud Molander Score, VAS for satisfaction, period of resumption to work, period of resumption to sports and period to pain free movement); 2) Medical parameters and safety (range of motion, clinical consolidation, radiologic consolidation, hardware failure and infection); 3) Biology of fracture healing (period to full weight bearing, degree of muscle wasting).

The hypothesis of this study is that direct weight-bearing after operative fixation of ankle fractures, will shorten the period of assumption to work and/or sports and improve the range of motion of the affected ankle.

1. 2 weeks;

2. 6 weeks;

3. 12 weeks;

4. 6 months;

5. 12 months.

1. Unprotected non-weight-bearing mobilisation with active exercises and crutches;

2. Protected weight-bearing with a conventional walking cast;

3. Unrestricted weight-bearing mobilisation with active exercises.