Tests were conducted on the basis of evaluating drill guide performance and operation when used as a tool to execute an ALLR procedure in conjunction with ACLR. Out of all our functional requirements, the testing protocol aimed to assess three important ones: avoiding tunnel convergence, adjustability, and minimizing the number of portals. Tunnel convergence is the main objective of the guide and testing will confirm that the drill guide design can be oriented in such a way that drills an ALLR procedural tunnel while ensuring that conflict with the ACLR tunnel does not occur. Adjustability is also crucial since patients vary in size and therefore different knee sizes should be accommodated for.
Outline of the testing protocol can be found here.
The first test for Dune was a success and was able to avoid tunnel conflict.
The second test was a failure since the drill damaged the pencil (the pencil represents the ACL graft– if this were a real patient, they would need yet another ACLR surgery). This failure occurred because the correct angle was not explicitly indicated on the guide; future iterations will include correct angle indications.
The final test was a second success, proving that the prototype has potential for future more advanced prototyping. Adjustability was not fully evaluated since there were only three trials in total. This metric will be revisited during the next testing protocol.
These tests highlight that Dune is capable of avoiding tunnel conflict. Changes will be made to improve the design such as including a fail safe and indicating the correct drilling angle for the next prototype, however, we are optimistic that this design idea will be successful.
The chart above indicates that the Dune prototype was only sometimes successful. This is attributed to the lack of a specified drill angle, impacting reliability.
*Fail – pencil had drill marks indicating a tunnel convergence.
*Adjustability was not able to fully be tested in this prototype due to the small amount of trials.
For more information on the testing evaluation, visit the testing protocol found here.