RESULTS OF A REGULATED CLINICAL TRIAL OF THE ACROBOT® SCULPTOR HANDS-ON ROBOTIC SYSTEM FOR UNICOMPARTMENTAL KNEE ARTHROPLASTY

Abstract

The primary objective of this study was to evaluate the performance of the Acrobot^® Sculptor system in achieving a surgical plan for implantation of unicompartmental knee prostheses, compared with conventional surgery. The Acrobot^® Sculptor is a novel hands-on medical device, consisting of a high speed cutter mounted on a robotic device which the surgeon holds and directs.

A prospective, randomised, double-blind (patient and evaluator), controlled versus conventional surgery study was undertaken and has been fully reported in Journal of Bone and Joint Surgery (British), 88-B.

All (13 out of 13) of the Acrobot^® cases were implanted with tibio-femoral alignment in the coronal plane within ±2° of the planned position, while only 40% (six out of 15) of the conventionally performed cases achieved this level of accuracy.

There was also a significant enhancement in the extent of post-operative improvement, as measured by American Knee Society (AKS) Scores at six weeks, in the cases implanted with the Acrobot^®. The difference between type of surgery is statistically significant (p=0.004, Mann-Whitney U test). Operating time (skin to skin) is higher in Acrobot treated subjects, but the difference between the two types of surgery fails to reach significance.

The Acrobot^® System was found to significantly improve both accuracy and short term outcome in this investigation. By permitting the creation of bone surfaces that can be machined by means other than an oscillating saw, the Acrobot^® System paves the way for novel implant designs to be developed, facilitating bone conserving arthroplasty in the knee, hip and spine with a new generation of even less invasive but more reliable procedures.