HIP REPLACEMENT REVISIONS TRIAL

Other complications were comparable with total hip replacements performed using conventional techniques. No intraoperative femoral fractures occurred in 900 cases. In these cases the surgical time declined quickly from 240 minutes for the first case to 90 minutes. The Harris hip score rose from 43.7 to 91.5. The German study reports on 858 patients, 42 with bilateral hip replacements and this includes 30 revision cases for a total of 900 hip replacements.

Complications were not different, except for three cases of intraoperative femoral fracture in the control group and none in the ROBODOC® group. Radiographs were evaluated by an independent bone radiologist and showed statistically better fit and positioning of the femoral component in the ROBODOC® group. This was attributed to a learning curve at each center. Length of stay also was not different, but the surgical time and blood loss were greater in the ROBODOC® group. No differences were found in the Harris hip scores or the Short Form Health Survey outcomes questionnaire. Followup was 1 year on 127 hip replacements and 2 years on 93 hip replacements.

The United States study is controlled and randomized with 136 hip replacements performed at three centers (65 ROBODOC® and 62 control).

HIP REPLACEMENT REVISIONS TRIAL

The combined experience of the United States Food and Drug Administration multicenter trial and the German postmarket use of the system are reported. The system consists of a preoperative planning computer workstation (called ORTHODOC) and a five-axis robotic arm with a high speed milling device as an end effector. The ROBODOC® system was designed to address potential human errors in performing cementless total hip replacement.

Hip replacement revisions