Abstract
Background
Surgeons are waiting for a hassle free, time saving, precise and accurate guide for hip arthroplasty. Industry are waiting for instruments to reduce manufacturing costs associated with washing, assembling, sterilization and transportation. Patient specific / custom made surgical guides may deliver these goals but current systems have had limited assessments.
We comprehensively assessed a new guiding system for the acetabular component of hip replacement, “Bullseye”.
Methods
Planning. We used either Computer Tomography (CT) (n=22) or Magnetic Resonance (MR) (n=6) imaging to plan the position of acetabular components into 28 acetabulums of cadavers (n=12) and dry bone models (n=16). 10 of the dry bone models had complex deformities (crowe 4 hip dysplasia or Paprosky 3A defects).
Surgical positioning. Patient specific “Bullseye” guides were manufactured using 3D printing and standard instruments were used to ream the acetabulum, guided by Bullseye, and position cup components.
Post surgery. The pelvises underwent CT scanning after implantation of acetabular cups. 3D software measured the “radiographic” (as opposed to operative or anatomic) cup inclination and version angles using the anterior pelvic plane as a reference. Achieved position was compared to the plan.
Statistics. We used Bland Altman plots to quantify the strength of the agreement between the planned and achieved cup orientations in terms of fixed bias, correlation coefficient and 2 standard deviation limits of agreement.
Results
Measurement of the cup position angles with 3D CT after implantation with the Bullseye hip instruments showed a median (Interquartile range) difference in degrees between planned and achieved position of 2.5 (1–6) for inclination and 8 (3–10) for version.
The use of CT or MR imaging for planning produced similar results.
Bland Altman plots for cup inclination and version angles respectively, showed a fixed bias of +3 and +6 degrees; in other words the guide increased the planned cup angles by consistent 3 and 7 degrees on average. The estimated bias, was 3.9 and 7 degrees respectively. The 95% (1.96 SD) limits of agreement were 7 and 10 respectively.
Discussion
This robust assessment, involving the use of 3D CT, of the Bullseye hip instruments system showed good early results with 95% limits of agreement between planned and achieved cup angles of 7.3 and 10 degrees for inclination and version respectively. In other words, the Bullseye instruments can achieve better cup position than any published study of conventional techniques. Or put another way, a cup planned to be at the centre of Lewinnek's safe zone of acetabular cup position (inclination range between 30 and 50 degrees; version range between 5 and 25 degrees) would be achieved in 95% of cases. This could be improved further by adjusting for the fixed bias and choosing cases with simple bony anatomy.
Conclusion
The Bullseye hip instruments have the potential to reduce the wide variation in the positioning of acetabular components during hip arthroplasty. It is now ready for a clinical evaluation.
