Abstract
Summary
Biomechanically, a 2° screw deviation from the nominal axis in the PFLCP leads to significantly earlier implant failure. Screw deviation relies on a technical error on insertion, but in our opinion cannot be controlled intraoperatively with the existing instrumentation devices.
Background
Several cases of clinical failure have been reported for the Proximal Femoral Locking Compression Plate (PFLCP). The current study was designed to investigate the failure mode and to explore biomechanically the underlying mechanism. Specifically, the study sought to determine if the observed failure was due to technical error on insertion or due to implant design.
Methods
To exclude patient and fracture type related factors, an abstract foam block model simulating an unstable pertrochanteric fracture was created for three study groups with six specimens each (n=6). Group 1 was properly instrumented according to the manufacturer's guidelines. In Group 2 and 3, the first or second screw was placed in a posterior or anterior off-axis orientation by 2° measured in the transversal plane, respectively. Each construct was tested cyclically until failure using a test setup and protocol simulating complex axial and torsional loading. Radiographs were taken prior to and after the tests. Force, number of cycles and failure mode were compared.
Results
The 2° screw deviation from the nominal axis led to significantly earlier construct failure in Group 2 and 3. The failure mode consisted of loosening of the off-axis screw due to disengagement with the plate, resulting in loss of construct stiffness and varus collapse of the fracture.
Conclusions
In our biomechanical test setup, a screw deviation of only 2° from the nominal axis consistently led to the failure mode observed clinically. In our opinion, screw deviation mostly relies on technical error on insertion. But, proper screw insertion may be difficult or impossible with the existing instrumentation devices, especially as it cannot be controlled or guaranteed intraoperatively.