Post operative evaluation of quality of life and pain in ankle fractures: cast immobilisation versus functional treatment

Completed

• Conditions: Ankle fracture; broken ankle; 10017322; 10005944

• Registration Number: NL-OMON35100
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Age 18-65 at the time of surgery
Ankle fractures needing operative correction
Weber type B or C, Lauge Hansen type supination-adduction, supination-exorotation and pronation-exorotation
Uncomplicated fractures
Postoperative stable for exercise
Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem

Exclusion Criteria

-Complicated (open) fractures
-Fractures with dislocation of the ankle joint
-Body Mass Index > 30
-Previous ankle fracture on the affected side
-Concomitant traumatic injuries reducing the ability for postoperative mobilization
-Pre-existent use of pain medication, medication affecting fracture- and wound healing
-Postoperative unstable for exercise
-Co-morbidity: pain syndromes, Fontaine IIB, III and IV, symptomatic venous insufficiency, auto-immune disorders, rheumatic arthritis

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quality of life (RAND 36)<br /><br>Function (goniometer, dynamometer, KOFOED)<br /><br>Pain (VAS/NRS, pain medication, KOFOED), </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Swelling (volumetric, figure of eight)<br /><br>Daily activities and work (lower limb task questionnaire, resumption of work)<br /><br>Disabilities (pain disability index)<br /><br>Complications<br /><br>Epidemiology</p><br>