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Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00690651
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : June 9, 2010
Sponsor:
Collaborator:
National Trauma Research Institute
Information provided by:
The Alfred

Tracking Information
First Submitted Date  ICMJE June 2, 2008
First Posted Date  ICMJE June 4, 2008
Last Update Posted Date June 9, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
length of acute hospital stay [ Time Frame: various ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
length of acute hospital stay [ Time Frame: various ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
  • wound integrity [ Time Frame: 10-14 days ]
  • readmission rate [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
wound integrity [ Time Frame: 10-14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?
Official Title  ICMJE Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Ankle Injuries
  • Fracture
Intervention  ICMJE
  • Procedure: 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)
  • Procedure: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Standard mobilization
  • Experimental: 1
    mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle
    Intervention: Procedure: Early mobilization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2008)
104
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients who have had internal fixation of a fractured ankle closed without plastic surgery intervention and without follow up hyperbaric oxygen therapy

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690651
Other Study ID Numbers  ICMJE 166/08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ms Lara kimmel, The Alfred
Study Sponsor  ICMJE The Alfred
Collaborators  ICMJE National Trauma Research Institute
Investigators  ICMJE
Principal Investigator: Lara a Kmmel, BA. Physio Bayside Health
Study Director: Anne Holland, Dr Physio Bayside Health
PRS Account The Alfred
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP