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Clinical Trials/NCT02823275
NCT02823275
Terminated
Not Applicable

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

Rijnstate Hospital2 sites in 1 country13 target enrollmentJanuary 2012
ConditionsAnkle Fractures

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle Fractures
Sponsor
Rijnstate Hospital
Enrollment
13
Locations
2
Primary Endpoint
pain
Status
Terminated
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
November 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rijnstate Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

pain

Time Frame: 6 weeks

Visual Analog Pain Scale

Pain medication used

Time Frame: 6 weeks

amount of pain medication used

Study Sites (2)

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