In order to enhance the acceptance of computer assisted surgery in joint replacement, a development-cooperation with BrainLAB, Germany was set up to develop a user-friendly handheld navigation device. A sterile draped Apple® IPod-Touch which is placed into a hardcover cradle, is used as navigation monitor and touchscreen control. Different instruments, such as navigation-pointer are attached to the cradle. In addition the workflows for TKR and THR procedures have been optimised. Therefore the main focus for TKR is navigation of femoral and tibial resection as well as leg alignment control. For the THR the system enables an intraoperative control of leg-length and femoral-offset measurement in comparison with the preoperative situation. Each step of the procedure is supported by video animations of the specific navigation workflow.

Between September and December 2010 the first clinical study on the usability in TKR and THR was performed for 20 cases using a prototype system. The study was approved by the local ethic committee and the “German Federal Institute for Drugs and Medical Devices (BfArM)”. Special interest was taken to the aspects of usability and the necessary time periods for specific steps of the procedure. Usability was measured for specific time periods of the procedure assessment of the usability of the surgical team. In addition postoperative x-rays were evaluated for implant position, leg alignment for TKR and hip joint geometry for THR cases.

Throughout the study for each assigned patient the procedure could be performed as planned. Several design inputs were identified for further improvement of the final system. Therefore time measurements of the first five cases were excluded.

For the TKR cases the registration process of the last 5 cases was less than 3 minutes. The interval for the tibial resection was between 3 and 7 minutes (aligning tibial cutting block – end of tibial verification). The interval for the distal femur resection was between 7 and 11 minutes (aligning femoral cutting block – end of femoral verification). All 10 Patients showed a final leg alignment on the postoperative standing x-ray within the save-zone of +/− 3° from neutral alignment. For the THR cases the preoperative registration period including the femoral head resection and acetabular registration was between 7 and 12 Minutes. Each final measurement of the hip geometry was done in less than 2 minutes. The evaluation of the pelvic ap-x-ray pre- and postoperative showed equivalent measurements of the new hip geometry compared with the intraoperative measured values. No specific complications occurred throughout the study.

In conclusion the BrainLAB–DASH-System has shown a high grade of usability and very short learning curve within this first clinical study. The use of a standard Apple® IPod-touch as a user interface seems to enhance the acceptance of the navigation technique. Equivalent precision compared to standard navigation systems have been demonstrated.

Introduction: Restoration of neutral alignment of the leg is an important factor affecting the long-term results of total knee arthroplasty (TKA). Recent developments in computer-assisted surgery have focused on systems for improving TKA. To verify that computer assistance improves the leg alignment and the component orientation, we present a single center study with 1000 patients.

Materials and Methods: In a prospective study two groups of 500 patients each undergoing TKA had operations using either a computer-assisted image free navigation system or a conventional technique. Alignment of the leg and the orientation of components were determined on post-operative long-leg coronal and lateral films.

Results: The mechanical axis of the leg was significantly better in the computer-assisted group (97%, within ±3° varus/valgus) compared with the conventional group (78,5%, within ±3° varus/valgus). The coronal alignment of the femoral component was also more accurate in the computer-assisted group.

Discussion: Computer-assisted TKA gives a better correction of alignment of the leg and orientation of the components compared with the conventional technique. Potential benefits in the long-term outcome and functional improvement require further investigation.

In a prospective randomised clinical study acetabular components were implanted either freehand (n = 30) or using CT-based (n = 30) or imageless navigation (n = 30). The position of the component was determined post-operatively on CT scans of the pelvis.

Following conventional freehand placement of the acetabular component, only 14 of the 30 were within the safe zone as defined by Lewinnek et al (40° inclination sd 10°; 15° anteversion sd 10°). After computer-assisted navigation 25 of 30 acetabular components (CT-based) and 28 of 30 components (imageless) were positioned within this limit (overall p < 0.001). No significant differences were observed between CT-based and imageless navigation (p = 0.23); both showed a significant reduction in variation of the position of the acetabular component compared with conventional freehand arthroplasty (p < 0.001). The duration of the operation was increased by eight minutes with imageless and by 17 minutes with CT-based navigation.

Imageless navigation proved as reliable as that using CT in positioning the acetabular component.

Restoration of neutral alignment of the leg is an important factor affecting the long-term results of total knee arthroplasty (TKA). Recent developments in computer-assisted surgery have focused on systems for improving TKA.

In a prospective study two groups of 80 patients undergoing TKA had operations using either a computer-assisted navigation system or a conventional technique. Alignment of the leg and the orientation of components were determined on post-operative long-leg coronal and lateral films.

The mechanical axis of the leg was significantly better in the computer-assisted group (96%, within ±3° varus/valgus) compared with the conventional group (78%, within ±3° varus/valgus). The coronal alignment of the femoral component was also more accurate in the computer-assisted group.

Computer-assisted TKA gives a better correction of alignment of the leg and orientation of the components compared with the conventional technique. Potential benefits in the long-term outcome and functional improvement require further investigation.