Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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?
Scientific title
Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.
Secondary ID [1] 0 0
166/08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle Injuries 0 0
Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
length of acute hospital stay
Timepoint [1] 0 0
various
Secondary outcome [1] 0 0
wound integrity
Timepoint [1] 0 0
10-14 days
Secondary outcome [2] 0 0
readmission rate
Timepoint [2] 0 0
30 days

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3204 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Trauma Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00690651
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lara a Kmmel, BA. Physio
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00690651