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

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.