Ankle InjuriesNCT00690651
Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?
A study testing Early mobilization and Standard mobilization in people with Ankle Injuries and Fracture, run by The Alfred at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankle Injuries, Fracture
- What is being tested?
- Early mobilization and Standard mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have had internal fixation of a fractured ankle closed without plastic surgery intervention and without follow up hyperbaric oxygen therapy
Who cannot join
- living in nursing home,
- previously non-ambulant,
- concommitant injuries which do not allow early mobilisation, plastics involvement for wound closure, hyperbaric oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ankle Injuries, Fracture
- Being tested
- Early mobilization, Standard mobilization
- Keywords
- ankle, fracture, mobilisation, bed rest, internal fixation
- Medical subject headings
- Ankle Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilizationProcedure or surgery
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)
Standard mobilizationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Standard mobilization |
| 1 | Experimental | mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle Receives: Procedure: Early mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: various
Secondary outcomes (2)
wound integrity
Measured: 10-14 days
readmission rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- National Trauma Research Institute
- Investigators
- Lara a Kmmel, BA. Physio, Principal investigator, Bayside HealthAnne Holland, Dr Physio, Study director, Bayside Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690651
- Sponsor's protocol ID
- 166/08
- Status last verified
- Jan 2010
- First submitted
- 2 Jun 2008
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.
- ClinicalTrials.gov ID
- NCT00690651
- Acronym / sponsor ID
- 166/08
- Conditions
- Ankle Injuries, Fracture
- Keywords
- ankle, fracture, mobilisation, bed rest, internal fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- National Trauma Research Institute
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: Standard mobilizationthis 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. |
| 1 | Experimental | Procedure: Early mobilizationmobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who have had internal fixation of a fractured ankle closed without plastic surgery intervention and without follow up hyperbaric oxygen therapy
Key exclusion criteria (3 listed)
- living in nursing home,
- previously non-ambulant,
- concommitant injuries which do not allow early mobilisation, plastics involvement for wound closure, hyperbaric oxygen therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early mobilizationpt 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 or surgery | 1 |
| Standard mobilizationthis 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. | Procedure or surgery | 2 |
Primary outcome
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)
2 secondary outcomes
wound integrity
Time frame: 10-14 days
readmission rate
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara a Kmmel, BA. Physio principal investigator
Bayside Health
Anne Holland, Dr Physio study director
Bayside Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization and Standard mobilization in people with Ankle Injuries and Fracture, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of acute hospital stay (time frame: various). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.