We are using a non image based navigation system on a routine basis for unicompartmental knee replacement (UKR). We prospectively studied 60 patients who underwent navigated minimally invasive UKR for primary medial osteoarthritis at our hospital between October 2005 and October 2006. We established a navigated control group of 60 patients who underwent conventional implantation of a UKA at our hospital between April 2004 and September 2005. There were 42 male and 78 female patients with a mean age of 65 years (range, 44–87 years). There were no differences in all preoperative parameters between the two groups. The accuracy of implant positioning was determined using predischarge standard anteroposterior and lateral radiographs. The following angles were measured: femorotibial angle, coronal and sagittal orientation of the femoral component, coronal and sagittal orientation of the tibial component. When the measured angle was in the expected range, one point was given. The accuracy was defined as the sum of the points given for each angle, with a maximum of five points (all items fulfilled) and a minimum of 0 point (no item fulfilled). Our primary criterion was the radiographic accuracy index on the postoperative radiograph evaluation. All other items were studied as secondary criteria. The mean accuracy index was similar in the two groups: 4.1 ± 0.8 in the study group and 4.2 ± 1.2 in the control group. 36 patients (60%) in the control group and 37 patients (62%) in the study group had the maximum accuracy index of five points. All measured angles were similar in the two groups. There were no differences between the percentages of patients in the two groups achieving the desired implant positions. Mean operating time was similar in the two groups. There were no intraoperative complications in either group. The groups had similar major postoperative complication rates during hospital stay (3% for both). The used navigation system is based on an anatomic and kinematic analysis of the knee joint during the implantation. The modification of the existing software for minimal invasive approach has been successful. It enhances the quality of implantation of the prosthetic components and avoids the inconvenient of a smaller incision with potential less optimal visualization of the intra-articular reference points. However, all centers observed a significant learning curve of the procedure, with a significant additional operative time during the first implantations. The postoperative rehabilitation was actually easier and faster, despite the additional percutaneous fixation of the navigation device. This system has the potential to allow the combination of the high accuracy of a navigation system and the low invasiveness of a small skin incision and joint opening.
Revision total knee replacement (TKR) is a challenging procedure, especially because most of the standard bony and ligamentous landmarks used during primary TKR are lost due to the index implantation. However, as for primary TKR, restoration of the joint line, adequate limb axis correction and ligamentous stability are considered critical for the short- and long- term outcome of revision TKR. There is no available data about the range of tolerable leg alignment after revision TKR. However, it is logical to assume that the same range than after primary TKR might be accepted, that is ± 3° off the neutral alignment. One might also assume that the conventional instruments, which rely on visual or anatomical alignments or intra- or extra-medullary rods, are associated with significant higher variation of the leg axis correction, especially in cases with significant bone loss which prevents to control the exact location of the usual, relevant landmarks. Navigation system might address this issue. We used an image-free system (ORTHOPILOT TM, AESCULAP, FRG) for routine implantation of primary TKR. The standard software was used for revision TKR. Registration of anatomic and cinematic data was performed with the index implant left in place. The components were then removed. New bone cuts as necessary were performed under the control of the navigation system. The size of the implants and their thickness was chosen after simulation of the residual laxities, and ligament balance was adapted to the simulation results. The system did not allow navigation for intra-medullary stem extensions and any bone filling which may have been required. This technique was used for 54 patients. The accuracy of implantation was assessed by measuring following angles on the post-operative long-leg radiographs: mechanical femoro-tibial angle (normal = 0°, varus deformation was described with a positive angle); coronal orientation of the femoral component in comparison to the mechanical femoral axis (normal = 90°, varus deformation was described with an angle <
90°); coronal orientation of the tibial component in comparison to the mechanical tibial axis (normal = 90°, varus deformation was described with an angle <
90°); sagittal orientation of the tibial component in comparison to the proximal posterior tibial cortex (normal = 90°, flexion deformation was described with angle <
90°). Individual analysis was performed as follows: one point was given for each fulfilled item, giving a maximal accuracy note of 4 points. Prosthesis implantation was considered as satisfactory when the accuracy note was 4 (all fulfilled items). The rate of globally satisfactory implanted prostheses and the rate of prostheses implanted within the desired range for each criterion were recorded. Limb alignment was restored in 88%. The coronal orientation of the femoral component was acceptable in 92% of the cases. The coronal orientation of the tibial component was acceptable in 89% of the cases. The sagittal orientation of the tibial component was acceptable in 87% of the cases. Overall, 78% of the implants were oriented satisfactorily for the four criteria. The navigation system enables reaching the implantation objectives for implant position and ligament balance in the large majority of cases, with a rate similar to that obtained for primary TKA. The navigation system is a useful aid for these often difficult operations, where the visual information is often misleading.
Navigation systems are able to measure very accurately the movement of bones, and consequently the knee laxity, which is a movement of the tibia under the femur. These systems might help measuring the knee laxity during the implantation of a total (TKR) or a unicompartmental (UKR) knee replacement. 20 patients operated on for TKR (13 cases) or UKR (7 cases) because of primary varus osteoarthritis have been analyzed. Pre-operative examination involved varus and valgus stress X-rays at 0 and 90° of knee flexion. The intra-operative medial and lateral laxity was measured with the navigation system at the beginning of the procedure and after prosthetic implantation. Varus and valgus stress X-rays were repeated after 6 weeks. X-ray and navigated measurements before and after knee replacement were compared with a paired Wilcoxon test at a 0.05 level of significance. The mean pre-operative medial laxity in extension was 2.3° (SD 2.3°). The mean pre-operative lateral laxity in extension was 5.6° (SD 5.1°). The mean pre-operative medial laxity in flexion was 2.2° (SD 1.9°). The mean pre-operative lateral laxity in flexion was 6.7° (SD 6.0°). The mean intra-operative medial laxity in extension at the beginning of the procedure was 3.6° (SD 1.7°). The mean intra-operative lateral laxity in extension at the beginning of the procedure was 3.0° (SD 1.3°). The mean intra-operative medial laxity in flexion at the beginning of the procedure was 1.9° (SD 2.6°). The mean intra-operative lateral laxity in flexion at the beginning of the procedure was 3.5° (SD 2.7°). The mean intra-operative medial laxity in extension after implantation was 2.1° (SD 0.9°). The mean intra-operative lateral laxity in extension after implantation was 1.9° (SD 1.1°). The mean intra-operative medial laxity in flexion after implantation was 1.9° (SD 2.5°). The mean intra-operative lateral laxity in flexion after implantation was 3.0° (SD 2.8°). The mean post-operative medial laxity in extension was 2.4° (SD 1.1°). The mean post-operative lateral laxity in extension was 2.0° (SD 1.7°). The mean post-operative medial laxity in flexion was 4.4° (SD 3.3°). The mean post-operative lateral laxity in flexion was 4.7° (SD 3.2°). There was a significant difference between navigated and radiographic measurements for the pre-operative medial laxity in extension (mean = 1.4° – p = 0.005), the pre-operative lateral laxity in extension (mean = 2.6° – p = 0.01), the pre-operative lateral laxity in flexion (mean = 3.3° – p = 0.005). There was no significant difference between navigated and radiographic measurements for the pre-operative medial laxity in flexion (mean = 0.3° – p = 0.63). There was a significant difference between navigated and radiographic measurements for the postoperative medial laxity in flexion (mean = 2.5° – p = 0.004). There was no significant difference between navigated and radiographic measurements for the postoperative medial laxity in extension (mean = 0.3° – p = 0.30), the post-operative lateral laxity in extension (mean = 0.2° – p = 0.76), the post-operative lateral laxity in flexion (mean = 1.7° – p = 0.06). These differences were less than 2 degrees in most of the cases, and then considered as clinically irrelevant. The navigation system used allowed measuring the medial and lateral laxity before and after TKR. This measurement was significantly different from the radiographic measurement by stress X-rays for pre-operative laxity, but not statistically different from the radiographic measurement by stress X-rays for post-operative laxity. The differences were mostly considered as clinically irrelevant. The navigated measurement of the knee laxity can be considered as accurate. The navigated measurement is valuable information for balancing the knee during TKR. The reproducibility of this balancing might be improved due to a more objective assessment.
Revision TKR is a challenging procedure, especially because most of the standard bony and ligamentous landmarks are lost due to the primary implantation. However, as for primary TKR, restoration of the joint line, adequate limb axis correction and ligamentous stability are considered critical for the short- and long-term outcome of revision TKR. There is no available data about the range of tolerable leg alignment after revision TKR. However, it is logical to assume that the same range than after primary TKR might be accepted, that is ± 3° off the neutral alignment. One might also assume that the conventional instruments, which rely on visual or anatomical alignments or intra- or extramedullary rods, are associated with significant higher variation of the leg axis correction. We used an image-free system (ORTHOPILOT TM, AESCULAP, FRG) for routine implantation of primary TKA. The standard software was used for revision TKA. Registration of anatomic and kinematic data was performed with the index implant left in place. The components were then removed. New bone cuts as necessary were performed under the control of the navigation system. The size of the implants and their thickness was chosen after simulation of the residual laxities, and ligament balance was adapted to the simulation results. The system did not allow navigation for centromedullary stem extension and any bone filling which may have been required. This technique was used for 54 patients. The accuracy of implantation was assessed by measuring the limb alignment and orientation of the implants on the post-operative radiographs. Limb alignment was restored in 88%. The coronal orientation of the femoral component was acceptable in 92% of the cases. The coronal orientation of the tibial component was acceptable in 89% of the cases. The sagittal orientation of the tibial component was acceptable in 87% of the cases. Overall, 78% of the implants were oriented satisfactorily for the five criteria. The navigation system enables reaching the implantation objectives for implant position and ligament balance in the large majority of cases, with a rate similar to that obtained for primary TKA. The navigation system is a useful aid for these often difficult operations, where the visual information is often misleading. The navigation system used enables facilitated revision TKA.
Anterior cruciate ligament (ACL) reconstruction allows overall good results, but there is still a significant rate of failure. It is well accepted that the main reason for ACL reconstruction failure is a misplacement of tibial or femoral tunnels. Conventional techniques rely mainly on surgical skill for intra-operative tunnel placement. It has been demonstrated that, even by experienced surgeons, there was a significant variation in the accuracy of tunnel placement with conventional techniques. Navigation systems might enhance the accuracy of ACL replacement. 10 cadaver knees with intact soft-tissue and without any intra-articular abnormalities were studied. We used a non image based navigation system (OrthoPilot ®, Aesculap, Tuttlingen, FRG). Localizers were fixed on bicortical screws on the distal femur and on the proximal tibia. Both kinematic and anatomic registration of the knee joint were performed by moving the knee joint in flexion-extension and palpating relevant intra- and extra-articular landmarks with a navigated stylus. The most anterior, posterior, medial and lateral point of both tibial and femoral attachment of the ACL were marked with metallic pins. The navigated stylus was positioned on these points, and the system recorded its position in comparison to the bone contours. Subsequently, we performed conventional plain AP and lateral X-rays and a CT-scan, and measured the position of the pins in comparison to the bone contours. Finally, all measurements were made again with a caliper after disarticulating the knee joint. We calculated the center of the footprint as the mid-point between the four pins of both tibial and femoral attachment for each measurement technique. All measurements were expressed as percentages of the bone size to compensate for the different sizes. There were no significant difference in the paired measurements of the location of the ACL footprints on both femur and tibia between anatomic, radiographic, CT-scan and navigated measurements. There was a significant correlation between the paired measurements of the location of the ACL footprints on both femur and tibia with either measurement techniques. Anatomic measurement is the gold standard experimental technique for the positioning of the ACL foot-print, and CT-scan measurement is currently the gold standard technique in clinical situation. According to this reference, the position of ACL attachments on the tibia and on the femur can be accurately defined by the navigation system. Intra-operative measurement of the location of the bone tunnels during ACL replacement with this navigation system should be accurate as well.
Unicompartmental knee replacement (UKR) is accepted as a valuable treatment for isolated medial knee osteoarthritis. Minimal invasive implantation might be associated with an earlier hospital discharge and a faster rehabilitation. However these techniques might decrease the accuracy of implantation, and it seems logical to combine minimal invasive techniques with navigation systems to address this issue. The authors are using a non image based navigation system (ORTHOPILOT ™, AESCULAP, FRG) on a routine basis for UKR. We prospectively studied 60 patients who underwent navigated minimally invasive UKR for primary medial osteoarthritis at our hospital between October 2005 and October 2006. We established a navigated control group of 60 patients who underwent conventional implantation of a UKA at our hospital between April 2004 and September 2005. There were 42 male and 78 female patients with a mean age of 65 years (range, 44–87 years). There were no differences in all preoperative parameters between the two groups. The accuracy of implant positioning was determined using predischarge standard anteroposterior and lateral radiographs. The following angles were measured: femorotibial angle, coronal and sagittal orientation of the femoral component, coronal and sagittal orientation of the tibial component. When the measured angle was in the expected range, one point was given. The accuracy was defined as the sum of the points given for each angle, with a maximum of five points (all items fulfilled) and a minimum of 0 point (no item fulfilled). Our primary criterion was the radiographic accuracy index on the postoperative radiograph evaluation. All other items were studied as secondary criteria. The mean accuracy index was similar in the two groups: 4.1 ± 0.8 in the study group and 4.2 ± 1.2 in the control group. 36 patients (60%) in the control group and 37 patients (62%) in the study group had the maximum accuracy index of five points. All measured angles were similar in the two groups. There were no differences between the percentages of patients in the two groups achieving the desired implant positions. Mean operating time was similar in the two groups. There were no intraoperative complications in either group. The groups had similar major postoperative complication rates during hospital stay (3% for both). The used navigation system is based on an anatomic and kinematic analysis of the knee joint during the implantation. The modification of the existing software for minimal invasive approach has been successful. It enhances the quality of implantation of the prosthetic components and avoids the inconvenient of a smaller incision with potential less optimal visualization of the intra-articular reference points. However, all centers observed a significant learning curve of the procedure, with a significant additional operative time during the first implantations. The postoperative rehabilitation was actually easier and faster, despite the additional percutaneous fixation of the navigation device. This system has the potential to allow the combination of the high accuracy of a navigation system and the low invasiveness of a small skin incision and joint opening.
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.
There was no significant difference in the pre-operative data between both groups. The post-operative coronal group A and 17 cases in group B. The prosthesis was optimally implanted in 17 cases in group A and 18 cases in group B. No difference was statistically significant.
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.
Nowadays, longevity of total knee arthroplasties is very acceptable. Survivorship analyses demonstrate a success in a range of 80% to more than 95% over a period of more than ten years (1–4). However, long-term results largely depend, amongst other factors, on restoration of physiological alignment of the lower limb (5–11). Jeffery et al. (12) reported a three percent loosening rate over eight years when knees were correctly aligned whereas insufficient alignment lead to prosthetic loosening in 24 percent. Rand and Coventry (13) found a 90 percent survivorship rate at ten years when the mechanical axis was aligned in a range from nought to four degrees of valgus. Valgus position of more than four degrees or varus alignment resulted in only 71 percent and 73 percent of survivorship respectively. Recently, computer aided instrumentation systems (14,15) became available and preliminary results of small series were reported (16–17). The purpose of this study was to assess the accuracy of computer integrated instrumentation for knee alignment.
The OrthoPilot® represents a computer controlled image supported alignment system. A 3-D Optotrak™ camera localizes infra-red diodes fixed to rigid bodies within the surgical field. Thereby a spatial coordinate reference system is provided. The localizer is linked to a UNIX work station which performs the operative protocol using a graphical interface and a foot pedal. The rigid bodies are fixed to the bones by bicortical screws. An intraoperative kinematic analysis and various additional landmarks lead to definition of the centres of hip, ankle and knee joint and sizing of endoprosthetic components. With the use of LED-equipped alignment instruments the femoral and tibial resection planes are determined. The OrthoPilot® navigation system is not dependant on CT data and no additional preoperative planning is therefore necessary. A prospective comparative multicentre study in five institutions, four in Germany and one in France, was carried out. 821 patients with primary tricompartimental knee arthroplasty using the SEARCH LC knee (B|Braun AESCULAP) were included in the study. The OrthoPilot® Navigation system was used in 555 cases and 266 knees were implanted with the use of conventional instrumentation. At the three months follow-up alignment was assessed using standardized one leg stance radiographs with regard to the mechanical axis and the femoral and tibial angels in the coronal plane. For the lateral femoral and tibial angels standard lateral x-rays were used. Prosthetic alignment was verified by an independent observer.
The radiographically assessed results were subdivided into three groups. An error of ± one degree in the radiographical measurements and small deviations caused by the play of surgical instruments have to be considered. With respect to the femoral and tibial angels in the ap and lateral view the group of very good clinical results was, therefore, defined in the range between ninty degrees and ± two degrees. Deviations of three and four degrees from the optimum were classified as being clinically acceptable. Aberrations of more than four degrees were classified as outliers. When measuring the mechanical axis deviations from fully precise femoral and tibial angels may add up. For this reason zero degrees ± three degrees were rated as a very good result, deviations of four to five degrees were considered to be acceptable and alignment beyond five degrees from the optimum was classified as an unsatisfactory result.
35. 2% of the navigated cases were aligned at exactly zero degrees. This was achieved in only 24. 4% of the manual cases. 88. 6% of cases using navigation and 72. 2% in the manual group showed zero degrees and varus or valgus angles of up to three degrees. 8. 9% and 18. 1% of cases respectively showed deviations of four or five degrees of valgus or varus alignment representing an acceptable clinical result. In only 2. 5% of the navigation group aberrations of more than five degrees occurred. The rate of dissatisfying results was 9. 8% in the manual group.
In the navigation group 48. 1% of cases showed an alignment at exactly 90 degrees which was the case in only 33. 5% of the control group. Altogether, in 89. 4% of the navigated cases a very good result was observed. In the conventionally instrumented cases only 77. 1% very good results were found. There were 1. 6% outliers beyond the limits of four degrees in the navigation group in comparison to 4. 9% amongst the control cases.
Very good results with up to two degrees of deviation from a ninety degree position were obtained in 75. 5% of navigated cases and 70. 7% of manual cases. 37. 3% and 34. 6% respectively showed an ideal alignment of exactly ninety degrees. Unsatisfactory results were observed in 9. 5% of the navigated cases and 9. 4% of the manual cases.
58. 7% of the computer assisted and 40. 6% of the reference cases were exactly aligned at rectangles. All in all, in 91. 9% navigated and only 83. 5% manual cases a very good result was obtained. Only 1. 1% outliers had to be observed in the navigation group whereas 3. 4% unsatisfactory results were registered with manual technique.
44. 3% of the navigated cases and only 26. 7% of cases in the control group were aligned perpendicular to the dorsal tibial cortex, thus showing no posterior slope. Altogether, 81. 3% could be classified as very good clinical results in the computer assisted group. The corresponding rate of the manual group was 69. 9%. Equivalent values of 8. 6% in the navigation group and 8. 3% in the reference group were registered beyond the limits of four degrees deviation. The additional operation time for the use of the navigation system is calculated between eight and ten minutes after having passed through the learning curve.
Knee navigation facilitates proper alignment of endoprosthetic components and with the use of the Ortho-Pilot® system results are clearly more favourable in comparison to conventional instrumentation technique. In addition, the data obtained from literature demonstrate that the use of this navigation system contributes to reducing outliers in number. With the learning curve the OrthoPilot® alignment system proved to gain in reliability. Deviations from perfect alignment are still difficult to be classified into surgical or technical deficiencies. Many technical and software improvements which were introduced in the meantime will, in addition, contribute to reliability and time saving. Comparative studies with different navigation systems are not yet available. They might allow an even more profound insight into the possibilities and advantages or disadvantages of computer assisted knee alignment.
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