A RANDOMISED CLINICAL TRIAL COMPARING MINIMALLY INVASIVE SURGERY (MIS) TO CONVENTIONAL APPROACH IN HIP FRACTURES – PRELIMINARY RESULTS

Abstract

This study is a prospective randomised clinical trial which primary objective was to demonstrate the safety and efficacy of a single posterior mini-incision approach compared to a standard posterior approach for hemiarthroplasty in acute femoral neck fractures.

Fifty-five patients have been randomised: twenty-four patients in the mini-incision surgery group (MIS) and thirty-one patients in the standard incision group (STD). The mini-incision was defined as less than 8cm. Data were collected preoperatively and at four days, three and six weeks, three, six, twelve, and twenty-four months postoperatively. The Jaglal Lower Extremity Measurement (LEM) and the Time Up and Go (TUG) where evaluated. Secondary endpoints of pain, function, and quality of life where assessed by the components of the Harris hip Score and SF-36. Radiograghic outcomes where also evaluated.

The demographic data where similar between the two groups for age, gender, weight, type of anaesthesia used, pre-operative haemoglobin and preoperative comorbidities. There was no significant difference for operative time, blood losses, 72h postoperative haemoglobin and the need for transfusion therapy between the two groups. Also, there was no difference between the groups for post-operative morphine use and pain evaluation with the Visual Analog Scale. The functional assessment using the LEM, TUG, Harris Hip score and SF-36 scores did not demonstrate any statistically significant difference between mini and standard incision.

This study demonstrates that the clinical and functional outcomes measured are similar between the two groups, thus limiting the potential benefits of MIS in hip fracture patients.