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

Primary Purpose

Ankle Injuries, Fracture

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Early mobilization
Standard mobilization
Sponsored by
The Alfred
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring ankle, fracture, mobilisation, bed rest, internal fixation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Alfred

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

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.

mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

wound integrity
readmission rate

Full Information

First Posted
June 2, 2008
Last Updated
June 8, 2010
Sponsor
The Alfred
Collaborators
National Trauma Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00690651
Brief Title
Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?
Official Title
Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Alfred
Collaborators
National Trauma Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Fracture
Keywords
ankle, fracture, mobilisation, bed rest, internal fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
1
Arm Type
Experimental
Arm Description
mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle
Intervention Type
Procedure
Intervention Name(s)
Early mobilization
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Standard mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
length of acute hospital stay
Description
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)
Time Frame
various
Secondary Outcome Measure Information:
Title
wound integrity
Time Frame
10-14 days
Title
readmission rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara a Kmmel, BA. Physio
Organizational Affiliation
Bayside Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Holland, Dr Physio
Organizational Affiliation
Bayside Health
Official's Role
Study Director
Facility Information:
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3204
Country
Australia

12. IPD Sharing Statement

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

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