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Sponsors and Collaborators: |
The Alfred National Trauma Research Institute |
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Information provided by: | The Alfred |
ClinicalTrials.gov Identifier: | NCT00690651 |
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.
Condition | Intervention |
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Ankle Injuries Fracture |
Procedure: Early mobilization Procedure: Standard mobilization |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures. |
Estimated Enrollment: | 104 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
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.
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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.
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1: Experimental
mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle
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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)
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lara A Kimmel, BA. Physio | 39-076-2000 ext 63450 | l.kimmel@alfred.org.au |
Contact: Melissa J Dixon, BA. Physio | 39-076-2000 ext 63450 | m.dixon@alfred.org.au |
Australia, Victoria | |
The Alfred | Recruiting |
Melbourne, Victoria, Australia, 3204 |
Principal Investigator: | Lara a Kmmel, BA. Physio | Bayside Health |
Study Director: | Anne Holland, Dr Physio | Bayside Health |
Responsible Party: | The Alfred ( Ms Lara kimmel ) |
Study ID Numbers: | 166/08 |
Study First Received: | June 2, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00690651 |
Health Authority: | Australia: Human Research Ethics Committee |
ankle fracture mobilisation bed rest internal fixation |
Ankle Injuries Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries |