Fri., 10/9/09 Hip & Geriatric, Paper #44, 11:05 am OTA-2009
A Randomized Clinical Trial Comparing Minimally Invasive Surgery to Conventional Approach for Endoprosthesis in Elderly Patients with Hip Fractures
G. Yves Laflamme, MD1 (n); Louis Roy, MD1 (n); Mathieu Carrier, MD1 (n);
Paul R. Kim, MD2 (n); Stephane Leduc, MD1 (n);
1Université of Montréal, Division Chirurgie Orthopédique, Hôpital du Sacré Coeur,
Montréal, Québec, Canada;
2Department of Surgery, University of Ottawa, Ottawa Hospital–General Campus,
Ottawa, Ontario, Canada
Background: In 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 technique. To our knowledge, the efficacy and safety of mini-incisions in hip fracture surgery has not been studied. The purpose of this study was to demonstrate the safety and efficacy of a single posterior mini-incision approach compared to a standard posterior approach for endoprothesis in acute femoral neck fractures.
Methods: 62 patients were prospectively randomized between the 2 surgery groups with a 10% mortality rate. The mini-incision was defined as less than 8 cm. 22 patients in the mini-incision surgery group (MIS) and 24 patients in the standard incision group (STD) were left for analysis. Data were collected preoperatively, as well as 4 days, 3 and 6 weeks, and 3, 6, 12, and 24 months postoperatively. The following validated disease-specific outcome instruments were used: the Lower Extremity Measurement (LEM) and the Time Up and Go (TUG). Secondary end points of pain, function, and quality of life were assessed by the components of the Harris hip Score (HHS) and Short Form-36 (SF-36). Radiographic outcomes were also evaluated, as well as the rates of all reported complications and adverse events during the 2-year follow-up.
Results: There was no significant difference for operative time, blood losses, 72-hour postoperative haemoglobin, and the need for transfusion therapy between the 2 groups. Also, there was no difference between the groups for postoperative morphine use and pain evaluation with the visual analog scale. The functional assessment using LEM and TUG did not demonstrate any statistically significant difference between MIS and STD. HHS and physical function of the SF-36 were statistically better at 2 years for the STD group.
Conclusion: Based on the results of the present study, we cannot recommend the use of a minimally invasive approach over a more standard approach in the implantation of a cemented endoprosthesis.
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant