L Roy1, G Y Laflamme, M Carrier, P R Kim, S Leduc. 1. Orthopaedic Surgery Division, Hôpital du Sacré Coeur, University of Montreal, 5400 Gouin Ouest, Room C-2080, Montréal, Québec, Canada.
Abstract
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 in a randomised fashion. METHODS: This study is a prospective clinically randomised trial whose primary objective was to demonstrate the safety and efficacy of a single posterior mini-incision approach compared to a standard posterior approach for endoprosthesis in acute femoral neck fractures. The mini-incision was defined as less than 8 cm. 25 patients in themini-incision surgery (MIS) group and 31 patients in the standard incision group (STD) were available for analysis. The following validated disease-specific outcome instruments were used: the Lower Extremity Measurement (LEM) and the Time Up and Go (TUG). Secondary endpoints of pain, function, and quality of life were assessed by the components of the Harris Hip Score (HHS) and SF-36. Radiographic outcomes were also evaluated as well as the rates of all reported complications and adverse events during the 2 years follow-up. RESULTS: There was no significant difference for operative time, blood losses, 72 h postoperative haemoglobin as well as the need for transfusion therapy between the two 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 mini- and standard incision. However, the HHS and the physical function component of the SF-36 were statistically better at 2 years in favour of the standard incision group. CONCLUSION: Based on the results of the present study, we cannot recommend the use of a minimally invasive approach over a standard approach in the implantation of a cemented endoprosthesis. Crown Copyright (c) 2009. Published by Elsevier Ltd. All rights reserved.
RCT Entities:
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 in a randomised fashion. METHODS: This study is a prospective clinically randomised trial whose primary objective was to demonstrate the safety and efficacy of a single posterior mini-incision approach compared to a standard posterior approach for endoprosthesis in acute femoral neck fractures. The mini-incision was defined as less than 8 cm. 25 patients in the mini-incision surgery (MIS) group and 31 patients in the standard incision group (STD) were available for analysis. The following validated disease-specific outcome instruments were used: the Lower Extremity Measurement (LEM) and the Time Up and Go (TUG). Secondary endpoints of pain, function, and quality of life were assessed by the components of the Harris Hip Score (HHS) and SF-36. Radiographic outcomes were also evaluated as well as the rates of all reported complications and adverse events during the 2 years follow-up. RESULTS: There was no significant difference for operative time, blood losses, 72 h postoperative haemoglobin as well as the need for transfusion therapy between the two 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 mini- and standard incision. However, the HHS and the physical function component of the SF-36 were statistically better at 2 years in favour of the standard incision group. CONCLUSION: Based on the results of the present study, we cannot recommend the use of a minimally invasive approach over a standard approach in the implantation of a cemented endoprosthesis. Crown Copyright (c) 2009. Published by Elsevier Ltd. All rights reserved.
Authors: Christian Ossendorf; Laurent Bohnert; Nadja Mamisch-Saupe; Daniel Rittirsch; Guido A Wanner; Hans-Peter Simmen; Claudio Dora; Clément Ml Werner Journal: Patient Saf Surg Date: 2011-04-17