Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment
Primary Purpose
Ankle Fractures
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Functional mobilisation
Short term plaster cast fixation
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fractures
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
Sites / Locations
- Rijnstate
- Radboud University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Functional mobilisation
plaster cast fixation
Arm Description
Outcomes
Primary Outcome Measures
pain
Visual Analog Pain Scale
Pain medication used
amount of pain medication used
Secondary Outcome Measures
Full Information
NCT ID
NCT02823275
First Posted
June 27, 2016
Last Updated
July 5, 2016
Sponsor
Rijnstate Hospital
Collaborators
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02823275
Brief Title
Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment
Official Title
Post Operative Evaluation of Quality of Life and Pain in Ankle Fractures: Cast Immobilisation Versus Functional Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Investigator changed jobs
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
Collaborators
Radboud University Medical Center
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional mobilisation
Arm Type
Active Comparator
Arm Title
plaster cast fixation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Functional mobilisation
Intervention Description
functional mobilisation
Intervention Type
Other
Intervention Name(s)
Short term plaster cast fixation
Intervention Description
2 weeks cast immobilisation
Primary Outcome Measure Information:
Title
pain
Description
Visual Analog Pain Scale
Time Frame
6 weeks
Title
Pain medication used
Description
amount of pain medication used
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rijnstate
City
Arnhem
State/Province
Gelderland
Country
Netherlands
Facility Name
Radboud University
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
12. IPD Sharing Statement
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Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment
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