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

Abstract

In the recent years, the concept of minimally invasive surgery has invaded the orthopaedic field and literature on the subject is spawning. Mini-incision surgery for total hip arthroplasty has been studied without a clear consensus on the efficacy, safety and advantage of that innovative technique. To our knowledge, the efficacy and safety of mini-incisions in hip fracture surgery has not been studied.

This study is a prospective clinical randomized 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. The mini-incision was defined as less than 8 cm. To date, 45 patients have been randomized between the two surgery groups has follows: 22 patients in the mini-incision surgery group (MIS) and 23 patients in the standard incision group (STD). Data were collected preoperatively as well as 4 days, 3 and 6 weeks, 3, 6, 12, and 24 months postoperatively. The following validated disease-specific outcome instruments where used: the Jaglal Lower Extremity Measurement (LEM) and the Time Up and Go (TUG). 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 as well as the rates of all reported complications and adverse events during the two years follow-up.

The demographic data where similar between the 2 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 2 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.