Uncemented megaprosthesis stem fixation using “Scratch Fit” to achieve improved implant fixation

Background: Despite a proposed lower incidence of aseptic loosening, uncemented distal femoral implants present challenges with the intra-operative assessment of the adequacy of stem fixation within the femoral canal. Our biomechanical study was intended to assess the adequacy of oncologic implant press-fit stem fixation within the reamed canal of the distal femur for the Stryker GMRS oncologic distal femoral implant. We hoped to answer the following: #1 Does the initial stem placement in the femoral canal using a standardized force (50 N) (i.e., “Scratch Fit”) predict the (adequacy)stability of the final stem placement (and implant fixation) within the femoral canal? #2 Is there a difference in the uncemented stem fixation and stability within the femur for different stem (Stryker GMRS) diameters (13, 14, and 15 mm) for the Stryker GMRS uncemented press-fit stems/(Stryker Global Orthopaedics) Methods: Femoral cadaveric specimens were thawed and cut at the distal end of the femur, at 13 cm from the distal joint line, to e represent a distal femoral tumor resection. Stryker GMRS uncemented stems were placed, after femoral reaming, into the distal femoral canal with firm, hand pressure applied via a customized, spring-based insertion tool positioned over the standard Stryker insertion tool and calibrated to apply a standard stem insertion force of 50 N (11.2 lbs). Initial stem placement, utilizing this method, resulted in a stem that was only partially implanted into the femur with a recorded distance (defined as “Scratch Fit”) between the stem collar and the cut surface of the femoral shaft. After completing final stem impaction into the femur, stem torsional testing was performed on a multi-axis biomechanical test frame with a 3-D Vicon motion-capture system with axial torsion applied to the stems with the proximal femur fixed to a potted base. Kinematics of both the implant and the distal femur were captured using the Vicon system which tracked reflective infrared targets at a 60 Hz sampling rate. The peak torsional moment at failure was compared to “Scratch Fit” metrics for each implant diameter to address the proposed research questions. Results: Scratch fit distances ranged from 7–46 mm with a mean of 29.1±12.7 mm. Peak torques ranged from 11.5 to 57.5 Nm with a mean of 33.6±17.0 Nm. Figure shows peak (max.) torque plotted against scratch fit for all stems/specimens with good correlation (r 2 =0.6404). When separated by stem diameters, figure shows strong correlations between peak torque and scratch fit. Conclusions: while there may be multiple metrics that affect uncemented stem implant placement and stability (i.e., femoral canal size, femoral reaming, and implant type/size (diameter), there appears to be some correlation between initial stem placement (i.e., “Scratch Fit”) after femoral reaming to implant torsional (rotational) stability; this correlation is stronger when controlled for stem diameter. This suggests that a greater initial “Scratch Fit” distance may provide improved press-fit stem fixation and may provide a better operative standard for making decisions regarding the fixation or stability of these implants.