Polyethylene wear is one of the reasons for failure of total knee replacement (TKR). There are several reasons for wear, and the femoro-tibial contact area is an important factor. Mobile bearing, highly congruent prostheses might be more resistant to polyethylene wear than fixed bearing, incongruent prostheses. We evaluated the 5- to 8-year experience of three university departments by using an original system with following highlights: implantation with a navigation system, extended congruency up to 90° of flexion, floating polyethylene component with non-limited movements of rotation, antero-posterior translation and medio-lateral translation. 347 patients have been operated on in the three participating departments with this new prosthesis system between 2001 and 2004, and have been prospectively followed with clinical and radiologic examination with a minimal follow-up time of 5 years. There were 246 women and 101 men, with a mean age of 67 years.INTRODUCTION
MATERIAL
Polyethylene wear is one of the reasons for failure of total knee replacement (TKR). There are several reasons for wear, and the femoro-tibial contact area is an important factor. Mobile bearing, highly congruent prostheses might be more resistant to polyethylene wear than fixed bearing, incongruent prostheses. We evaluated the five- to eight-year experience of three university departments by using an original system with following highlights: implantation with a navigation system, extended congruency up to 90° of flexion, floating polyethylene component with non-limited movements of rotation, antero-posterior translation and medio-lateral translation. 347 patients have been operated on in the three participating departments with this new prosthesis system between 2001 and 2004, and have been prospectively followed with clinical and radiologic examination with a minimal follow-up time of five years. There were 246 women and 101 men, with a mean age of 67 years. Clinical and functional results have been analyzed according to the Knee Society scoring system. Accuracy of implantation has been assessed on post-operative long leg antero-posterior and lateral X-rays. Survival rate up to eight years has been calculated according to Kaplan and Meier, with mechanical revision or any revision as end-points. Complete patient history was obtained by 319 cases (92%). The mean clinical score was 93 points. The mean pain score was 47 points. The mean flexion angle was 118°. The mean functional score was 87 points. An optimal correction of the coronal femoro-tibial axis was obtained in 94% of the cases. Survival rate after eight years was 98.8% for mechanical revisions and 95.5% for all revisions. We confirmed the influence of the navigation system on the accuracy of implantation. The clinical and functional results after five to eight years are in line with the better results of the current literature after conventional implantation of non-congruent prostheses. The survival rate is comparable to the current standards. The influence of the design on polyethylene wear will need a longer follow-up.
Accuracy of implantation is an accepted prognostic factor for the long term survival of total knee replacement (TKR). The use of navigation demonstrated a significant higher accuracy of implant orientation in comparison to conventional methods. However, these systems are often thought to be technically demanding, to increase operating time and to involve a long learning curve. We performed a prospective, multicenter study to compare the accuracy of implantation of a TKR measured on post-operative X-rays in experienced and less experienced centers. All centers used the same navigation system (Ortho-Pilot ®, Asculap, Tuttlingen, FRG): 4 had already a significant experience with it (group A – 182 cases), 9 centers were considered as beginners with less than 10 cases performed prior to the study (group B – 221 cases). Accuracy of implantation was measured on post-operative antero-posterior and lateral long leg X-rays with five items: mechanical femoro-tibial angle, coronal orientation of the femoral component, sagittal orientation of the femoral component, coronal orientation of the tibial component, sagittal orientation of the tibial component. When the measured angle was in the expected range, one point was given. The accuracy note was defined as the sum of all points given for each patient, with a maximum of 5 points (all items fulfilled) and a minimum of 0 point (no item fulfilled). The mean accuracy note was compared in the two groups by a Student t-test at a 0.05 level of significance. Power of the study was 0.80. There were no significant differences in pre-operative parameters between the two groups, except for the clinical KSS. The mean operative time was significantly longer in group B than in group A (110 minutes vs 90 minutes, p=0.01). However this difference occurred mainly during the first twenty cases in the beginner centres where we observed a clear tendency to achieve the same operative time as the experienced centres at the end of the study. The mean accuracy note was 4.3 ± 0.8 (range, 1 to 5) in the control group and 4.3 ± 0.9 (range, 1 to 5) in the study group (p >
0.05). The power of the study to detect a 0.25 point difference in the post-operative accuracy note was retrospectively calculated to be 0.80. There were no significant differences between the two groups for all individual radiographic items. This study is, to our knowledge, the first one which investigates the learning curve of navigated TKR The used navigation system allowed a very accurate implantation of a TKR in both experienced and less experienced centers. There was no detectable learning curve with respect to accuracy of TKR implantation, clinical outcome and complication rate. The duration of the learning curve when considering the operating time was 30 cases.
Frontal orientation of the femoral component was satisfactory in 89.4% of the knees in group 1 and in 77.1% in group 2. Sagittal orientation of the femoral component was satisfactory in 75.5% of the knees in group 1 and in 70.7% of the knees in group 2. Frontal orientation of the tibial component was satisfactory in 91.9% of the knees in group 1 and in 83.5% of the knees in group 2. The sagittal orientation of the tibial piece was satisfactory in 81.3% of the knees in group 1 and in 69.9% of the knees in group 2. Optimal implantation, considering all criteria studied, was achieved in 275 patients (49.5%) in group 1 and in 82 patients (30.8%) in group 2 (p<
à.001). Ther was no difference in results between centres.