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

Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.

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.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries; Fracture
• Intervention / Treatment: Procedure: Standard mobilization; Procedure: Early mobilization

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3204
      • The Alfred

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Experimental: 1; mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of acute hospital stay	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)	various

Secondary Outcome Measures

Outcome Measure	Time Frame
wound integrity	10-14 days
readmission rate	30 days

Collaborators and Investigators

• Sponsor: The Alfred
• Collaborators: National Trauma Research Institute
• Investigators: Principal Investigator: Lara a Kmmel, BA. Physio, Bayside Health; Study Director: Anne Holland, Dr Physio, Bayside Health

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: June 2, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (Estimate): June 4, 2008

Study Record Updates

• Last Update Posted (Estimate): June 9, 2010
• Last Update Submitted That Met QC Criteria: June 8, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: fracture; ankle; mobilisation; internal fixation; bed rest
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: 166/08