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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:
Sponsor: Rijnstate Hospital

Current Primary Outcome:

  • pain [ Time Frame: 6 weeks ]
    Visual Analog Pain Scale
  • Pain medication used [ Time Frame: 6 weeks ]
    amount of pain medication used


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rijnstate Hospital

Dates:
Date Received: June 27, 2016
Date Started: January 2012
Date Completion:
Last Updated: July 5, 2016
Last Verified: June 2016