Unilateral Unstable Hip Clinical Trial
Official title:
Outcome Following Stabilization of Fresh Unilateral Unstable Pertrochanteric Hip Fracture With Either the Endovis BA2 Cephalomedullary Nail or the Dynamic Hip Screw: A Single Centre, Feasibility Study
This is a preliminary study to establish the issues and potential of the investigators
proposed project, which involves recruitment of patients with and without dementia, who have
been admitted to hospital following hip fractures. The study will be evaluating the result
of treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is
restored leading to their independence. These patients would require surgical fixation (not
replacement) of their hip fractures.
The study will evaluate two methods of fixation of hip fractures treated with either a pin
(nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate
which is applied on the outer aspect of the thigh bone.
The data collected from this study will provide information on whether one method of
fixation is better than the other.
The investigators have organised a Patient Feedback Session in Leeds, comprising of patients
who previously sustained hip fractures and who underwent surgical fixation (either
cephalomedullary nail or dynamic/sliding hip screw). According to the feedback that was
provided, the most important issue highlighted was how quickly the patients regain their
functional capacity (mobility) and by inference their independence and overall quality of
life, to pre-injury levels. The length of hospital stay was also an important parameter in
their judgement.
Based on this patient feedback session, the design of a study evaluating the result of
treatment of unstable pertrochanteric hip fractures should focus on how soon mobility is
restored leading to their independence. Moreover, using the length of hospital stay as a
secondary outcome would not only act as a surrogate of mobility (hospital discharge is
determined by ability to safely mobilize), but would have huge implication to health care
cost as well, which is considered as a major contributor for the majority of the overall
hospital costs. Finally, it has been shown that up to 50% of hip fracture patients have
dementia, which has been reported to be an independent risk factor of poor outcome following
hip fractures. The investigators can therefore argue that it is even more important that
this cohort of patients be treated with a superior implant, and thus be included in studies.
However, currently, there is limited experience with regards to clinical trials which
involve surgical patients with dementia, particularly on issues of consent, recruitment and
retention/follow-up. This was highlighted by a recent review, who found that 8 out of 10 hip
fracture trials excluded or ignored the patient population with cognitive impairment.
However, with up to one in three patients with hip fractures presenting simultaneously with
some degree of dementia, this is an important population to include.
The investigators therefore propose concept feasibility study, to investigate the
feasibility of running a study involving patients with and without dementia to investigate
the outcome of unstable pertrochanteric fractures (AO/OTA type A2), comparing the
implantation of the Endovis BA 2 cephalomedullary nail (device conferring biomechanical
advantage) to the Dynamic/Sliding Hip Screw (current "gold standard").
Patients who fulfill the inclusion and exclusion criteria, will be invited to participate in
this study. Following patient or patient's carer/personal or nominated consultee providing
informed consent/assent to participate in the study they will be randomized using an online
randomisation tool, by permuted blocks, stratified for cognitive status (AMTS<8/≥8).
The abbreviated mental test score (AMTS) can rapidly assess elderly patients for the
possibility of dementia and can assess for confusion and other cognitive impairment. The
doctor seeing the patient will conduct the AMTS as standard of care.
Although patients will not be told of their allocation but cannot be considered blinded as
they may guess which group they have been allocated based on the incision size. The assessor
for clinical outcomes, such as the TUG assessment will be blinded to group allocation.
Following surgery, patients will be followed-up at week 2, 4 and 12 post-operation (as per
standard of care practice). Information collected during these visits will include, hip
X-rays, functional scores (Lower Extremity Measure, London Handicap Scale, DEMQOL), TUG
(Timed Up and Go) test, complications/adverse events and concomitant medication
requirements.
Within standard care patients undergo the above stages, the only extra measures with this
research project from the above are the Lower Extremity measure, London Handicap Scale and
TUG test.
Lower Extremity Measure will be used on patients with AMTS score ≥8 only whereas London
Handicap Scale will be used on patients with AMTS score ≥8 only.
The TUG test involves standing up from a seated position, walking three metres, turning
around, and then walking three metres back to chair and returning to the seated position.
The TUG times will be noted down.
The extra measures besides the TUG test are questionnaires which will be given to patients
to complete with the help of the Research Nurse.
The DEMQOL will involve carers completing the Carer part of the DEMQOL questionnaire. For
those patients coming from nursing home's the nursing home staff will complete the DEMQOL
carer questionnaire.
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