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

NCT02823275 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-07-06

No results posted yet for this study

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

Conditions

  • Ankle Fractures

Interventions

OTHER

Functional mobilisation

functional mobilisation

OTHER

Short term plaster cast fixation

2 weeks cast immobilisation

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Rijnstate Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02823275 on ClinicalTrials.gov