In Vivo Calibration of a Femoral Fixation Device Transducer for Measuring Anterior Cruciate Ligament Graft Tension: A Study in an Ovine Model

2001 ◽  
Vol 123 (4) ◽  
pp. 355-361 ◽  
Author(s):  
Isaac Zacharias ◽  
Stephen M. Howell ◽  
M. L. Hull ◽  
Keith W. Lawhorn

Toward developing a transducer for measuring in vivo tension in anterior cruciate ligament grafts in humans, the objectives of this study were to determine the following: (1) whether the calibration of a previously reported femoral fixation device transducer (FDT) (Ventura et al., 1998) is affected by the presence of the graft when implanted in the tibial metaphysis of an ovine model, (2) whether the FDT remains calibrated at 4 weeks postoperatively, and (3) whether the biological incorporation of the graft occurs prior to a change in the FDT calibration. The FDT was implanted in the hind limb of five sheep using an extra-articular procedure. Both the proximal common digital extensor tendon (i.e., graft) and a Teflon-coated wire were looped around the FDT inside a tunnel in the tibial metaphysis. The FDT was calibrated on three occasions using the loop of wire: once intraoperatively before graft insertion, once intraoperatively after graft insertion, and once postoperatively after the animals had been sacrificed at 4 weeks. Following sacrifice, the load transmitted to the FDT by the graft was also determined. The FDT exhibited linear calibration intraoperatively both before and after graft insertion with an average error relative to the calibration before insertion of the graft of −4.6 percent of full-scale load (150 N) and this average relative error was not significantly different from zero p=0.183. After 4 weeks of implantation, the average relative percent error was −5.0 percent and was not significantly different from zero p=0.434 indicating that the FDT remained calibrated in the in vivo environment. Because only 15 percent of the graft tension was transmitted to the FDT after 4 weeks, biological incorporation of the graft preceded the loss of calibration. In light of these findings, the FDT offers the capability of measuring the intra-articular ACL graft tension in vivo in animal models and possibly humans before the biological bond develops and also of monitoring the formation and maturation of the biological bond between a graft and bone tunnel.

2000 ◽  
Vol 122 (6) ◽  
pp. 600-603 ◽  
Author(s):  
Isaac Zacharias ◽  
M. L. Hull ◽  
Stephen M. Howell

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. [S0148-0731(00)00606-3]


1998 ◽  
Vol 120 (3) ◽  
pp. 327-333 ◽  
Author(s):  
C. P. Ventura ◽  
J. Wolchok ◽  
M. L. Hull ◽  
S. M. Howell

The goal of this study was to develop a new implantable transducer for measuring anterior cruciate ligament (ACL) graft tension postoperatively in patients who have undergone ACL reconstructive surgery. A unique approach was taken of integrating the transducer into a femoral fixation device. To devise a practical in vivo calibration protocol for the fixation device transducer (FDT), several hypotheses were investigated: (1) The use of a cable versus the actual graft as the means for applying load to the FDT during calibration has no significant effect on the accuracy of the FDT tension measurements; (2) the number of flexion angles at which the device is calibrated has no significant effect on the accuracy of the FDT measurements; (3) the friction between the graft and femoral tunnel has no significant effect on measurement accuracy. To provide data for testing these hypotheses, the FDT was first calibrated with both a cable and a graft over the full range of flexion. Then graft tension was measured simultaneously with both the FDT on the femoral side and load cells, which were connected to the graft on the tibial side, as five cadaver knees were loaded externally. Measurements were made with both standard and overdrilled tunnels. The error in the FDT tension measurements was the difference between the graft tension measured by the FDT and the load cells. Results of the statistical analyses showed that neither the means of applying the calibration load, the number of flexion angles used for calibration, nor the tunnel size had a significant effect on the accuracy of the FDT. Thus a cable may be used instead of the graft to transmit loads to the FDT during calibration, thus simplifying the procedure. Accurate calibration requires data from just three flexion angles of 0, 45, and 90 deg and a curve fit to obtain a calibration curve over a continuous range of flexion within the limits of this angle group. Since friction did not adversely affect the measurement accuracy of the FDT, the femoral tunnel can be drilled to match the diameter of the graft and does not need to be overdrilled. Following these procedures, the error in measuring graft tension with the FDT averages less than 10 percent relative to a full-scale load of 257 N.


2019 ◽  
Vol 5 (1) ◽  
pp. 505-507
Author(s):  
Mira Dreier ◽  
Samuel Bachmayer ◽  
Christian Baumgartner ◽  
Jörg Schröttner

AbstractAlong with increasing enthusiasm for sports comes an increase of sport related injuries. One of the most common injuries in the human knee is the tear of the anterior cruciate ligament (ACL). The selection of a graft fixation device is an important factor that determines the outcome of an anterior cruciate ligament reconstruction. Before the healing process is completed, the graft is dependent on tibial and femoral fixation devices to maintain normal ACL graft tension. Among various devices, the use of an adjustable loop suspensory fixation device (ALD) in soft-tissue graft reconstruction attracts current interest. An advantage of the ALD is the ability to draw the graft to the depth of the bone tunnel to achieve adequate graft tension while minimizing the empty space in the tunnel. In this study a comprehensive controlled laboratory investigation is performed to examine the biomechanical properties of commonly used cortical fixation devices, with the aim of implementing a standard testing procedure for adjustable loop devices. The procedure consists of three test series, a loop shortening test and two different stability test series (singe device and tendon device test). Those test series are used to compare the performance of a new ALD from Arthrex (Naples, USA) with five competitor devices already on the market. In order to obtain representative results eight samples of each device are tested. In comparison to the previously performed studies, a complete unloading is applied in the stability tests, which allows for a detailed examination of the ALDs locking mechanisms in dynamically loaded test situations. Furthermore, the performed loop shortening tests reveal important aspects, such as the shortening accuracy and settling effects of the loops, that are not found in previous studies. Therefore, the used test protocol can be recommended for further testing.


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