Prospective randomized study: early weight bearing after conservative treatment of stable ankle fractures.

Recruiting

• Conditions: broken ankle; stable ankle fracture; 10017322

• Registration Number: NL-OMON46747
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 284

Inclusion Criteria

- Age of 16 years and older.
- Stable ankle fracture (non-dislocated Weber B or Lauge Hansen supination-eversion stage 2-4A fracture, isolated malleolus tertius fracture)
- Conversative treatment with a belowknee plaster cast.

Exclusion Criteria

- Age below 16 years.
- Weber A ankle fracture.
- Unstable ankle fracture.
- Fractures involving both lower extremities.
- Operative treatment of the ankle fracture.
- Posttraumatic period more than 10 days.
- Amputation of upper leg, lower leg or foot.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Functional outcome scores of the ankle. This will be indicated with the<br /><br>Olerud/Molander Ankle Function Score (OMAS). This is a continuous variable<br /><br>(0-100 points).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Dislocation of the fracture within 6 weeks (after placement of the Walker or<br /><br>circular lower limb plaster cast). This is a dichotomous variable (yes/no).<br /><br><br /><br>Other study parameters<br /><br>Range of motion (ROM) of the ankle and circumference of the calf (physical<br /><br>examination), return to work, mental health outcome scores (SF-36<br /><br>questionnaire) and other complications, such as deep vein thrombosis or<br /><br>surgery.</p><br>