Fractured Hip Clinical Trial
Official title:
Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?: A Randomised Controlled Trial
Hip fractures are a significant problem for healthcare providers due to the increasing
incidence of fractures in an ageing population. Hip fracture is the most frequent fracture
for people over 80 years of age and the second most frequent for those over 65 years. It is
projected that by 2051, 23% of the Australian population will be older than 65 and the
number of hip fractures will rise fourfold (17,000 in 2004, to 60,000 in 2051).
Evidence-based clinical practice guidelines regarding management of hip fracture were
published in the Medical Journal of Australia in 1999 and updated in 2003. Seventeen aspects
of treatment were systematically reviewed, including mobilisation after surgery. Early
assisted ambulation within 48 hours post surgery was recommended (Chilov 2003 p 490).
However, the recommendation was based on observational (level 3) evidence only.
Early mobilization post surgery is resource intensive. Early mobilization is challenging and
uncomfortable for the patient and requires the assistance of one or sometimes two,
physiotherapists available seven days per week. Benefits must be rigorously evaluated to
justify recommendation. We undertook a randomized controlled trial of the effect of two
different ‘time to first ambulation’ intervals after hip fracture surgery on patient and
hospital outcomes.Our hypothesis was that early mobilisation would accelerate functional
recovery after hip fracture surgery.
Methods Inclusions: Consecutive patients admitted via the emergency department to The Alfred
hospital Melbourne, for surgical fixation of an acute fracture of the hip (by a compression
screw and plate or a hemiarthroplasty).
Exclusions:fracture was pathological, postoperative orders were for non-weight bearing on
the operated hip, the patient was admitted from a nursing home or the patient was
non-ambulant pre-morbidly.
Sixty eligible patients were randomly allocated, using a computer generated program, into
one of two groups.
Management All patients received routine, standard post-operative medical and nursing
clinical care, as currently practiced at The Alfred. All patients were transferred to sit
out of bed as early as possible after surgery.
Ambulation The physiotherapy ambulation re-education program was implemented once per day
over 7 days for all participants. The time to first walk differed between the groups.
Data collection On admission: gender, age, preoperative mobility, social supports, mental
ability and medical comorbidity,pre-existing medical comorbidity (cardiac, respiratory,
neurological, diabetes) and mental ability.
Additional data from each patients medical record including: type of surgical fixation
(nail/screw and plate, hemi-arthroplasty), wait time to surgery, time surgery completed, and
time to first sit out of bed and time to first walk.
Outcome measures The primary outcome measure was the patient’s functional level, represented
by the distance they walked and the level of assistance required to transfer from supine to
sit and sit to stand and to negotiate one step, on day-7 post surgery.
Secondary outcome measures included discharge destination and length of stay in the acute
care (days from admission to discharge from The Alfred).
Data analysis Statistical analysis was performed using SAS version 8.2. (SAS Institute
Inc.,Carv, NC, USA). Continuous variables were compared using student t-tests and validated
using Wilcoxon rank sum tests. Categorical variables were compared using chi-square tests
for equal proportion. A two-sided p-value of 0.05 was considered to be statistically
significant.
Sample size A difference between groups equivalent to one standard deviation was perceived
to be of clinical importance. With 30 subjects per group, this study had a 97% power to
detect a difference equal to one standard deviation with a two-sided p-value of 0.05. A
minimum of 16 subjects per subgroup was required for this study to have an 80% power to
detect a difference equal to one standard deviation with a two-sided p-value of 0.05.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03224195 -
Patient Experience of Acute Rehabilitation After Hip Fracture
|
||
| Completed |
NCT03407573 -
Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur
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N/A |