Introduction and Objective. Total knee arthroplasty (TKA) is a frequently and increasingly performed surgery in the treatment of disabling knee osteoarthritis. The rising number of procedures and related revisions pose an increasing economic burden on health care systems. In an attempt to lower the revision rate due to component malalignment and soft tissue imbalance in TKA, robotic assistance (RA) has been introduced in the operating theatre. The primary objective of this study is to provide the results of a theoretical, preliminary
Summary. Alignment results did not differ between PSG and conventional instrumentation. A small reduction in operation time and blood loss was found with the PSG system, but is unlikely of clinical significance. Length of hospital stay was identical for both groups. Introduction. Several techniques for aligning a TKA exist nowadays. Patient-specific guiding (PSG) has relatively recently been introduced to try to resolve the shortcomings of existing techniques while optimising the operative procedure. Still few reports have been published on the clinical outcome and on the peroperative results of this new technique. This prospective, double-blind, randomised controlled trial was designed to address the following research questions: 1. Is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA. 2. Is there a significant difference in operation time, blood loss and length of hospital stay between the 2 techniques. Patients & Methods. 180 patients were randomised for PSG TKA (group 1) or conventional TKA (group 2) in 2 centres. Patients were stratified per hospital. Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital, standing, long-leg and standard lateral radiographs by 2 independent outcome assessors in both centres. Percentages of outliers, > 3°, were determined. We compared blood loss, operation time and length of hospital stay. Results. There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups. No statistically significant difference was found for the alignment of the individual components in the frontal plane, nor for the percentages of outliers. There was a statistically significant difference in outliers for the femoral component in the sagittal plane, with a higher percentage of outliers in the group 1 (p = 0.017). No such significant result was found for the tibial component in that plane. All interclass correlation coefficients were good. Blood loss was 100 mL less in group 1 (p = 0.000). Operation time was 5 minutes shorter in group 1 (p = 0.000). Length of hospital stay was almost identical with a mean of 3.6 days (p = 0.657). Discussion/Conclusions. The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups. A small reduction in operation time and blood loss was found with the PSG system, but is unlikely of any clinical significance. Future research should especially focus on
This protocol describes a pragmatic multicentre
randomised controlled trial (RCT) to assess the clinical and cost
effectiveness of arthroscopic and open surgery in the management
of rotator cuff tears. This trial began in 2007 and was modified
in 2010, with the removal of a non-operative arm due to high rates
of early crossover to surgery. Cite this article: