Purpose: The aim of this study was to perform a comprehensive biomechanical examination of frequently applied femoral cortical suspension devices, comparing the properties of both fixed and adjustable fixation mechanisms. It was hypothesized that adjustable loop devices demonstrate less consistent fixation properties with increased variability compared to fixed loop devices.
Methods: Nine frequently applied fixation button types were tested, six adjustable and three rigid loop devices. Six samples of each device type were purchased. Each device was installed in a servo-hydraulic mechanical testing machine, running a 2000 cycle loading protocol at force increments between 50 and 500 N. Irreversible displacement in mm was measured for all of the tested samples of each implant. Ultimately, maximum load to failure was applied and measured in Nm. An irreversible displacement of 3 mm was considered failure of the implant.
Results: Three of the six adjustable devices (GraftMax™, TightRope® ToggleLoc™) demonstrated a median displacement above the threshold of clinical failure before completion of the cycles. All adjustable loop devices showed a wide intragroup variation in terms of irreversible displacement, compared to fixed-loop devices. Fixed-loop devices provided consistent reproducible results with narrow ranges and significantly lower irreversible displacement (p < 0.05), the maximum being 1.4 mm. All devices withstood an ultimate force of more than 500 N.
Conclusion: Adjustable loop devices still show biomechanical inferiority and demonstrate heterogeneity of fixation properties with wide- and less-reproducible displacement ranges resultant to the mechanism of adjustment, denoting less reliability. However, three adjustable devices (RIGIDLOOP™ Adjustable, Ultrabutton ◊, ProCinch™) demonstrate fixation capacities within the margins of clinical acceptance. RIGIDLOOP™ Adjustable provides the most comparable fixation properties to fixed loop devices.
Keywords: ACL TightRope®; ACL reconstruction; ACL repair; Adjustable button; ENDOBUTTON◊ CL ULTRA; Femoral cortical suspension device; Fixed button; GraftMax™; Irreversible displacement; ProCinch™; RIGIDLOOP; RIGIDLOOP™ Adjustable; RetroButton; ToggleLoc™; Ultrabutton◊.