The WOW! Study, Weight-bearing or Non-Weight bearing. A prospective randomised multicenter comparison of three different care regimens after operatively fixed ankle fractures.

Completed

Conditions: operated ankle fractures
operatively fixed ankle fractures
10017322

Registration Number: NL-OMON43927

Lead Sponsor: Diakonessenhuis Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 225

Inclusion Criteria

patients from 18-65 years
fractures classified as Lauge Hansen supination-eversion type 2,3 or 4
articular discongruity of > 2 mm on radiograph (international indication for surgery)

Exclusion Criteria

Pre-existent impaired mobility
Pre-existent cognitive disability
Expected insufficiently stable fracture fixation with standard surgical technique
Use of syndesmosis screw
Tertius fragment which requires operative fixation
Body Mass Index > 30
Diabetes mellitus
Polytrauma patients (ISS>16 or >2 AIS regions involved)
Gustilo 2 and 3 open fractures
Inability to comply with non-weight bearing mobilisation (i.e. due to other injuries / co-morbidity)
Inability to comply with follow-up (for example due to an inability to read or complete forms)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Olerud-Molander ankle score, 12 weeks after surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Olerud-Molander ankle score (6 weeks and 1 year after surgery)<br /><br>- Number of wound related problems<br /><br>- Number of hardware failures<br /><br>- Range of motion of the ankle (6 and 12 weeks and 1 year after surgery)<br /><br>- Weight bearing, calf wasting and muscle strength (6 and 12 weeks)<br /><br>- Radiologic consolidation (6 and 12 weeks and 1 year after surgery)<br /><br>- Patient satisfaction: VAS and SF-36 (6 and 12 weeks and 6 and 12 months)<br /><br>- Period of resumption to work<br /><br>- Period of resumption of sports<br /><br>- Analysis of weight distribution of the operatively fixed ankle </p><br>