Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment

Not Applicable

Terminated

• Conditions: Ankle Fractures
• Interventions: Other: Functional mobilisation; Other: Short term plaster cast fixation

• Registration Number: NCT02823275
• Lead Sponsor: Rijnstate Hospital

Brief Summary

Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work.

Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities.

Main study parameters/endpoints:

Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-05
• Last Update Submitted: 2016-07-05
• Study First Posted: 2016-07-06
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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-external rotation and pronation-external rotation
• Closed fractures
• Postoperative stable for exercise
• Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem

Exclusion Criteria

• Open fractures
• Fractures with complete 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: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional mobilisation	Functional mobilisation	-
plaster cast fixation	Short term plaster cast fixation	-

Primary Outcome Measures

Name	Time	Method
pain	6 weeks	Visual Analog Pain Scale
Pain medication used	6 weeks	amount of pain medication used

Trial Locations

Locations (2)

Rijnstate; 🇳🇱 Arnhem, Gelderland, Netherlands

Radboud University; 🇳🇱 Nijmegen, Gelderland, Netherlands