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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
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 27, 2016
Last Updated
July 5, 2016
Sponsor
Rijnstate Hospital
Collaborators
Radboud University Medical Center
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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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