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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00690651
Registration number
NCT00690651
Ethics application status
Date submitted
2/06/2008
Date registered
4/06/2008
Date last updated
9/06/2010
Titles & IDs
Public title
Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?
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Scientific title
Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.
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Secondary ID [1]
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166/08
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ankle Injuries
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Fracture
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Injuries and Accidents
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Early mobilization
Treatment: Surgery - Standard mobilization
Active comparator: 2 - this group will rest in bed with operated leg well elevated for 48 hour and then mobilize with physiotherapist with aim for discharge home when safe.
Experimental: 1 - mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle
Treatment: Surgery: Early mobilization
pt to get out of bed and mobilize with physiotherapist within 24 hours of surgery. they will be allowed toilet privileges and will go home when safe (as per medical staff and allied health)
Treatment: Surgery: Standard mobilization
this group will rest in bed with their leg elevated above their heart for 48 hours post surgery to ankle fracture and will then mobilize with physiotherapist with aim to discharge home.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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length of acute hospital stay
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Assessment method [1]
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The time frame is variable as the length of stay is variable depending on many factors (usually less than a week in acute hospital if no complications)
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Timepoint [1]
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various
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Secondary outcome [1]
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wound integrity
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Assessment method [1]
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Timepoint [1]
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10-14 days
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Secondary outcome [2]
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readmission rate
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Assessment method [2]
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Timepoint [2]
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30 days
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Eligibility
Key inclusion criteria
* patients who have had internal fixation of a fractured ankle closed without plastic surgery intervention and without follow up hyperbaric oxygen therapy
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* living in nursing home,
* previously non-ambulant,
* concommitant injuries which do not allow early mobilisation, plastics involvement for wound closure, hyperbaric oxygen therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2010
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Sample size
Target
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Accrual to date
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Final
104
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
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3204 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Trauma Research Institute
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
After a patient has fractured an ankle that then requires surgery, the recommendation is to remain in bed, with the operated leg elevated on pillows for 48 hours. This is a precautionary measure, as yet unsubstantiated by research, which is thought to minimize ankle swelling that can inhibit the healing of the surgical wound. However, prolonged bed rest can lead to other complications such as blood clots in the lungs or leg veins, or chest infections such as pneumonia. Prolonged bed rest is also known to cause weakness and a loss of fitness such that recovery may be slower. In this research the investigators will be randomly allocating patients to mobilize within 24 hours post operatively or to rest in bed for 48 hours with their leg well elevated. The investigators will measure length of stay and wound healing and integrity at 14 days. This study aims to investigate whether getting patients out of bed within 24 hours of surgery can accelerate recovery and reduce acute hospital length of stay without affecting wound healing. If bed rest for 2 days is not necessary, there will be benefits for the patient in terms of general health and ability, and for the hospital in terms of cost savings through shorter lengths of stay and patient through put. The investigators already know that early mobilization is beneficial following other types of orthopedic surgery such as hip fractures. This study aims to investigate if early mobilization following surgical management of ankle fractures is safe with specific regard to wound integrity and wound outcomes. This study will also investigate the effect of earlier mobilization on the length of time spent in the acute hospital and for those discharged directly home, the amount and type of support required. If early mobilization is found to be safe for wound healing and results in shorter in-hospital stays, this research will provide the confidence to endorse a change to current clinical practice.
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Trial website
https://clinicaltrials.gov/study/NCT00690651
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Lara a Kmmel, BA. Physio
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Address
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Bayside Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00690651
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