Static and fatigue strength of a fixation device transducer for measuring anterior cruciate ligament graft tension.
To determine which exercises do not overload the graft-fixation complex during intensive rehabilitation from reconstructive surgery of the anterior cruciate ligament (ACL), it would be useful to measure ACL graft loads during rehabilitative activities in vivo in humans. A previous paper by Ventura et al. (1998) reported on the design of an implantable transducer integrated into a femoral fixation device and demonstrated that the transducer could be calibrated to measure graft loads to better than 10 percent full-scale error in cadaveric knees. By measuring both the static and fatigue strengths of the transducer, the purpose of the present study was to determine whether the transducer could be safely implanted in humans without risk of structural failure. Eight devices were loaded to failure statically. Additionally, seven devices were tested using the up-and-down method to estimate the median fatigue strength at a life of 225,000 cycles. The average ultimate strength was 1856 +/- 74 N and the median fatigue strength was 441 N at a life of 225,000 cycles. The maximum graft load during normal daily activities is estimated to be 500 N and the 225,000 cycle life corresponds to that of the average healthy individual during a 12-week period. Considering that patients who have had an ACL reconstruction are less ambulatory than normal immediately following surgery and that biologic incorporation of the graft should be well developed by 12 weeks thus decreasing the load transmitted to the fixation device, the FDT can be safely implanted in humans without undue risk of structural failure.
Zacharias
I
I
Department of Mechanical Engineering, University of California, Davis, CA 95616, USA.
Hull
M L
ML
Howell
S M
SM
D000203:Activities of Daily Living; D016118:Anterior Cruciate Ligament / Q000637:transplantation*; D004867:Equipment Design; D004868:Equipment Failure; D006801:Humans; D016268:Internal Fixators; D008422:Materials Testing; D013314:Stress, Mechanical; D014025:Titanium; D014159:Transducers; D016474:Weight-Bearing
D014025:Titanium