Clinical trial NCT00690651: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Fracture
Keywords: ankle
fracture
mobilisation
bed rest
internal fixation
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: National Trauma Research Institute
First posted: 2008-06-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: length of acute hospital stay
timeFrame: various
Secondary outcomes:
measure: wound integrity
timeFrame: 10-14 days
measure: readmission rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
Study officials:
affiliation: Bayside Health
name: Lara a Kmmel, BA. Physio
role: PRINCIPAL_INVESTIGATOR
affiliation: Bayside Health
name: Anne Holland, Dr Physio
role: STUDY_DIRECTOR
References: