Comparison of robotic-assisted and manual implantation of a primary total hip replacement. A prospective study.

BACKGROUND: Robotic-assisted total hip replacement has become a common method of implantation, especially in Europe. It frequently has been postulated that robotic reaming would result in an improved clinical outcome due to the better fit of the prosthesis, but that has never been demonstrated in a prospective study, to our knowledge. The purpose of this study was to compare robotic-assisted implantation of a total hip replacement with conventional manual implantation.
METHODS: One hundred and fifty-four patients scheduled for total hip replacement were randomly assigned to undergo either conventional manual implantation of an S-ROM prosthesis (eighty patients) or robotic-assisted implantation of such a prosthesis (seventy-four patients). The five-axis ROBODOC was used for the robotic-assisted procedures. Preoperatively as well as at three, six, twelve, and twenty-four months after surgery, the scores according to the Harris and Merle d'Aubigné systems and the Mayo clinical score were determined. Radiographs made at these intervals were analyzed for evidence of loosening, prosthetic alignment, and heterotopic ossification.
RESULTS: Thirteen (18%) of the seventy-four attempted robotic implantations had to be converted to manual implantations as a result of failure of the system. The duration of the robotic procedures was longer than that of the manual procedures (mean and standard deviation,107.1 +/- 29.1 compared with 82.4 +/- 23.4 minutes, p < 0.001). Limb-length equality (mean discrepancy, 0.18 +/- 0.30 compared with 0.96 +/- 0.93 cm, p < 0.001) and varus-valgus orientation of the stem (mean angle between the femur and the shaft of the prosthesis, 0.34 degrees +/- 0.67 degrees compared with 0.84 degrees +/- 1.23 degrees, p < 0.001) were better after the robotic procedures. At six months, slightly more heterotopic ossification was seen in the group treated with robotic implantation. The group treated with robotic implantation had a better Mayo clinical score at six and twelve months and a better Harris score at twelve months; however, by twenty-four months, no difference was found between the groups with regard to any of the three scores. Dislocation was more frequent in the group treated with robotic implantation: it occurred in eleven of the sixty-one patients in that group compared with three of eighty in the other group (p < 0.001). Recurrent dislocation and pronounced limping were indications for revision surgery in eight of the sixty-one patients treated with robotic implantation compared with none of the seventy-eight (excluding two with revision for infection) treated with manual insertion (p < 0.001). Rupture of the gluteus medius tendon was observed during all of the revision operations.
CONCLUSIONS: The robotic-assisted technology had advantages in terms of preoperative planning and the accuracy of the intraoperative procedure. Disadvantages were the high revision rate; the amount of muscle damage, which we believe was responsible for the higher dislocation rate; and the longer duration of surgery. This technology must be further developed before its widespread usage can be justified.

RCT Entities:   Population Interventions Outcomes