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Assessment of External Fixator Reusability Using Load- and Cycle-Dependent Tests

Matsuura, Maiko, MS*; Lounici, Smain, MS*; Inoue, Nozomu, MD, PhD*; Walulik, Stephen, BS**; Chao, Edmund Y.S., PhD*

Clinical Orthopaedics and Related Research®: January 2003 - Volume 406 - Issue 1 - p 275-281
SECTION II ORIGINAL ARTICLES: Research
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No standard method has been established for investigating repeated use of an external fixator. The purpose of the current study was to establish a fatigue testing method for assessing fixator frame reuse. A unilateral DynaFix™ external fixator system was tested using high-load and low-cycle (900–150 N at 5 Hz) and low-load and high-cycle (450–100 N at 10 Hz) tests (assumed one use of 500,000 and 1 million cycles, respectively). These loading conditions were selected to simulate single clinical use and to satisfy Food and Drug Administration requirements. In the high-load low-cycle test, substantial failure of the serrated joint occurred before completion of the first simulated use. In the low-load high-cycle test, all fixators completed three simulated clinical uses without failure, although ¼ of the serrated joint components had hairline cracks. The high-load low-cycle test identified the fixator components which should be examined and replaced if reuse of the fixator is to be considered. Wear and deformation of the set screw on the rotary joint and telescoping mechanisms were observed in the low-load high-cycle test but not in the high-load low-cycle test. Therefore, if the unilateral DynaFix™ fixators are being considered for reusability, the number of reuses should be limited as the whole structure of the device will experience fatigue damage as the loading cycle increases.

From the *Orthopaedic Biomechanics Laboratory, Johns Hopkins University, Baltimore, MD; and **EBI, L.P., Parsippany, NJ.

This study was funded in part by a grant from Department of Defense and a gift from EBI, L.P., which also donated the fixator frames and pins for the investigation.

Reprints requests to Edmund Y. S. Chao, PhD, Orthopaedic Biomechanics Laboratory, Johns Hopkins University, School of Medicine, Room 235, Ross Building, 720 Rutland Ave., Baltimore, MD 21205-2196 Phone: 410-502-6416; Fax: 410-502-6414; E-mail: echao@jhmi.edu.

Received: April 11, 2001.

Revised: January 4, 2002; April 29, 2002.

Accepted: May 9, 2002.

DOI: 10.1097/01.blo.0000037443.23683.7c

External fixation has proven its efficacy in the treatment of bony and soft tissue injuries. Although external fixation is approved by the United States Food and Drug Administration for one use only, one recent cost-effectiveness study showed that reuse of external fixators could reduce the cost to the hospital and patient by 34% and 32%, respectively. 5

Major concerns with reusing a fixator are device integrity and the adequacy of subsequent fixation. The moving parts of the fixator body may slip and introduce angulations, 2,4,6–9,12,15 especially under repetitive loading, and such inadequate fixation or fixator failure can lead to malunion, 8 nonunion, 17 pseudarthrosis, 1 or refracture. 13,16 De Bastiani et al 4 reported on eight cases of unstable frames attributable to excessive reuse of the articulating components. Even though these fractures healed without angulation or rotation once the frame had been restored, such cases can result in complications. Therefore, the question remains whether a reused device can function adequately, meeting the biomechanical and biologic demands. However, no standard testing method has been established to investigate performance of the unilateral external fixator device under cyclic fatigue load, simulating multiple usage of the fixator frame.

In general, increasing the load or increasing the number of loading cycles, or both, accelerates fatigue behavior in testing. It is not clear whether these factors cause the same fatigue behavior in the external fixator or which factor may be more suitable for assessing the reusability of an external fixator. The rationales for selecting the current testing conditions were based on a simulated single use but under more severe loading, to follow similar testing criteria published in the literature, and to meet the Food and Drug Administration requirements. 3,12,14 Based on these loading and clinical application conditions, the authors tested the hypothesis that component deformity and stiffness values of external fixators are loading cycle dependent. In addition, it was assumed that the change in the structural stiffness of the fixator-bone construct and the reduction of pin bracket and joint loosening torques were indicative of fixator failure initiation, which could be used as criteria for device reusability evaluation after simulated clinical use.

The objective of the current study was to compare these two types of fatigue tests as tools with which to assess the reusability of the external fixator. The specific aims of this investigation were: (1) to monitor the stiffness property and loosening torque of the pin fixation bracket screws, the serrated joints, the rotary joint, and the telescoping mechanism to detect possible structure failure of the device under both loading conditions, (2) to examine the accumulated fixator component damages during the testing sequence, and (3) to recommend fixator reusability under different simulated application conditions according the testing results.

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MATERIALS AND METHODS

The DynaFix™ external fixator (EBI L.P., Parsippany, NJ) (Fig 1) was selected for testing because it has multiple types of joint mechanisms (serrated, telescoping, and rotary). Eight new harrow Delrin cylinders (E.I. duPont de Nemours & Co, Parkersburg, WV) with outer diameters of 38 mm and inner diameters of 19.3 mm were used as bone models. Six tapered cortical bone pins (EBI L.P., diameter tapered from 6–5 mm; 150 mm long, with a 50-mm threaded portion) were used to construct a three-pin configuration for each pin clamp. The pins were placed at 90° to the long axis of the cylinders (Fig 2). Cerrobend alloy (Cerro Metal Products, Bellefonte, PA) was poured into each cylinder to secure the pins and to minimize pin tract failure under the severe loading condition.

Fig 1.

Fig 1.

Fig 2.

Fig 2.

All mechanical tests were done on an MTS™ servohydraulic machine (MTS Model Bionix 858, MTS Systems Corporation, Eden Prairie, MN). To simulate a fracture, the Delrin cylinder was divided into halves. The unilateral DynaFix™ fixator was used to immobilize the Delrin cylindrical halves simulating the bone segments allowing no contact at the fracture site so that all loads would be transmitted through the pins to the fixator frame. Two metal balls were attached to each cylinder, one at the distal end and one at the proximal end, to allow rotation but constrain translation when placed in the custom loading jig. In the loading jig, the cylinder was oriented to simulate the anatomic axis of the femur 6° from the loading axis of the MTS™ testing machine. As a result of this orientation, the fixator was exposed simultaneously to mediolateral bending and axial compression. Such a loading configuration simulates a more realistic (clinical) condition than a simple axial configuration.

Of the eight new fixators tested, three were tested under a high-load of 900 N cycled with a minimum compression of 150 N at a frequency of 5 Hz (the high-load low-cycle test). Because all test specimens failed within simulated one-use under this loading condition, the remaining five fixators were used for a low compressive load of 450 N cycled with a minimum compression of 100 N at a frequency of 10 Hz (the low-load high-cycle test). Even though the test construct could be regarded as elastic, loading frequency could not be increased because of the hydraulic capacity of the testing machine. One use was defined as 1 million cycles for the low-load high-cycle test and 500,000 cycles for the high-load low-cycle test. 2,10,15 The low-load high-cycle test was used to simulate normal loading after fracture immobilization under the recommended partial weightbearing restrictions. The high-load low-cycle test was used to simulate abnormal loading conditions in which the patient would resume full weightbearing under external fixation against a physician’s advice. The frame deformation and load levels were monitored throughout the cycles via a linear variable displacement transducer and a load cell. Tests were done to simulate three uses unless abrupt fracture or permanent deformation was observed.

All fixator screws and joints were tightened with a digital torque wrench (Proto 6320, Stanley-Proto Industrial Tools, Covington, GA) to a torque of 27 N-m at the beginning of a new simulated use. The initial loosening torque for each screw was measured before the beginning of a new simulated use and the screws were tightened to 27 N-m. To facilitate fixator component inspection for possible damage during the fatigue test sequence, intermediate (half-use) and final (one-use) disassemblies of the fixator were done. At every half- (500,000 cycles) and full-use (1 million cycles) interval, all key components of the device were disassembled and inspected under a microscope (Stereoscopic zoom microscope, Cole-Palmer Instrument Co, Vernon Hills, IL) before reloading for the remaining cycles. The screw loosening torque was measured at the time of inspection, and each screw was retightened to the previously measured torque at every half-use interval. After every simulated use, all fixators were cleaned (STS duoTEK Inc, Model A98–095, Rush, NY) and sterilized (STS duoTEK Inc, Model M95–1580) according to the manufacturer’s recommendation.

Statistical analyses of deformation and stiffness were done using analysis of variance (ANOVA) treating the cycle number as the independent variable and the change in component deformation and fixator stiffness values as the dependent variables to study the proposed hypothesis with the Tukey-Kramer post hoc test. Significance was set at a probability less than 0.05.

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RESULTS

Structural Failure Reflected by Stiffness Reduction of the Fixator Construct

In the low-load high-cycle test, average frame deformation at 2 and 3 million cycles increased by 12.7% and 21.6%, respectively (Table 1), and the average stiffness at 2 and 3 million cycles decreased by 5% and 17% of the initial average stiffness, respectively. The average deformation and stiffness values at 0 to 0.5 million cycles and 0.5 to 1 million cycles were significantly different than values at 2.5 to 3 million cycles.

TABLE 1

TABLE 1

In the same low-load high-cycle test, initial loosening torque did not vary remarkably between the three simulated uses, although it generally decreased. Throughout the cycles, the most frequent sites of loosening were the inner screw of the proximally placed pin clamp and the outer screw of the distally placed pin clamp. Two fixators had loosening torque too small to be measured with the torque wrench (< 5 N-m): one had torque loosening at the outer screw of the distal pin clamp (1 million cycles) and at the inner screw of the proximally place pin clamp (2 million cycles); the second had torque loosening at the proximal serrated joint screw on the telescoping mechanism side and at the distal serrated joint screw on the rotary joint side, both at 3 million cycles. There was some plastic deformation observed at the tip and at the tip end threads of the rotary joint set screw and on the telescoping mechanism set screw, but these did not produce adverse effects on fixator stiffness performance.

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Component Damage Under Fatigue Test

In the high-load low-cycle test, the maximum deformations throughout the cycles, produced at the last loading cycle before failure, were 3.7, 4.9, and 5.1 mm (Table 2). These values were more than twice those in the last 1 million cycles of the high-cycle test. The deformities seen in the low-load high-cycle test caused by set screw wears were not detected in the high-load low-cycle test.

TABLE 2

TABLE 2

In the low-load high-cycle test, all five fixators completed the three simulated uses (3 million cycles) with no evidence of component fractures, angulation at the joints, sliding at the distracted telescoping mechanism, or permanent pin deformation. However, after two uses, hairline cracks were detected in four of the five fixators (there are four serrated joints in each fixator) on the anodized Al surface of the serrated joint component (Fig 3). Eight of the 10 hairline cracks occurred on the tension side under bending. Despite these hairline cracks and the reduction of structural stiffness that occurred during the third-use sequence in the low-load high-cycle test, the frames did not fail through excessive deformation or loss of set screw or joint tightening torque after the simulated three-uses test.

Fig 3.

Fig 3.

In the high-load low-cycle test, all three fixators failed before completing the first simulated use of 500,000 cycles (approximate values, 150,000, 430,000, and 180,000 cycles). Major failures, such as joint angulation and material fracture of serrated joints, were observed in all three fixators (Fig 4). Hairline cracks also were observed on the anodized surface of supporting part of the serrated joint.

Fig 4.

Fig 4.

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Estimated Reuse Criteria

Using the low-load high-cycle test condition, no appreciable component damage was seen in any of the five test specimens after two simulated uses (2 million cycles). The amount of structure stiffness decrease and screw and joint loosening torque reduction was insignificant during this testing period. However, consistent hairline cracks were observed on the anodized Al serrated joint components in four of five fixators during the third and final use test sequence. Therefore, it is reasonable to suggest that under normal partial weightbearing loading conditions, the DynaFix™ fixator could be reused for two consecutive applications in fracture treatment. Although all fixators went through three complete uses of 3 million cycles under low-load high-cycle conditions with minimal stiffness changes, the hairline cracks that occurred in the third use would strongly prevent reuse without replacement of the key components of the fixator to avoid catastrophic failure of the device.

In abnormally high loading conditions, none of the three test fixators completed the simulated short application of 500,000 cycles and the tests were terminated because of structural failure of excessive deformation and component fracture. Therefore, when a patient is suspected to have experienced full weightbearing activities, that fixator should be discarded regardless of how long it was used or how the end results of the treatment evolved. In no circumstance should the pins be reused regardless of the loading conditions and time involved.

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DISCUSSION

The testing configuration used in the current study exposed the fixator frame to a severe loading condition by combining axial and bending loads. Furthermore, the construct permitted rotational freedom, introducing relatively large deformation for the fixator and putting the fixator frame in a high-loading environment, especially when the load level was increased. The load magnitude used for this study was based on the average body weight of an adult man. 1,2,15 However, in the clinical setting, patients with a lower extremity external fixator are unlikely to bear the 900 N load simulated in the current study because of pain and discomfort. The load of 450 N was considered practical for partial weightbearing on a lower limb with an external fixator.

The cyclic load of 900 N produced fatigue failures of the serrated joint. Therefore, it was determined that the high-load low-cycle test could identify the structural part most prone to fatigue fracture in the fixator frame. However, the fatigue fracture occurred in the early stage of cyclic loading even before the completion of a simulated one-use under nonphysiologic, high-loading conditions. Such testing is necessary to determine which structural part may fail under high-loading conditions. However, such an excessive condition may not provide accurate predictions in normal clinical use to assess the reusability of an external fixator. Therefore, the data obtained from the high-load low-cycle test may be used to determine which component of the fixator should be checked and replaced when reuse is being considered.

In the low-load high-cycle test, the accumulated wear and deformation of tightening screws on the telescoping mechanism and the rotary joint were detected even though the load magnitude was smaller than that in the high-load low-cycle test. These fatigue behaviors seem to be related to the micromotion at joints and they might have been cycle-dependent rather than load-dependent. In the clinical setting, excessive loading may not occur in a routine fashion because of patients’ controlled responses regulated by pain. Considering normal use, the number of loading cycles seems to be an appropriate test parameter of external fixator reuse. However, the high-load test should be used in combination with the low-load test result in the overall evaluation of fixator reuse. Therefore, the number of loading cycles is of interest in determining the fatigue life of the external fixator and the timing for refurbishing or replacing damaged fixator components under normal loading whereas high-load test data will be used to determine which component of the fixator need to be replaced in recommending any reuse possibility.

It is probable that the severe wearing of the fixator parts was a product not only of the large number of cycles in the high-cycle test, but also of the repetitive tightening and loosening procedures (five before completing 3 million cycles), which should be considered when evaluating reuse of the fixator. In the clinical scenario, tightening of each screw should be monitored so that none are over-tightened or exceed its elastic limits. A previous study showed that there is an optimum tightening torque to prevent deleterious effects caused by under-tightening or over-tightening. 11

Although all fixators endured the 3 million cycles of simulated three-uses test in the low-load high-cycle conditions, the low loosening torque measured at several set screw sites and the hairline cracks observed on the surface of the serrated joints only after 2 million cycles of loading may suggest a possibility of impending failure which must be considered in recommending fixator reuse more than once under normal clinical applications involving lower extremity weightbearing conditions. 3,14

Each patient and each fracture are different; therefore, fixators may have various degrees of load transmission. Duration of fixation, levels of weightbearing, and the patient’s weight and level of activity all must be considered in judging fixation frame reusability. However, inspecting fixator components and certifying their performance standards are time consuming and involve additional cost and device liability concerns. For practical and safety reasons, the DynaFix™ unilateral fixator may be considered for limited reuse based on the current study results. In a low-load condition, the current data suggest that the DynaFix™ unilateral fixator frame could be considered for one-time reuse provided that critical components containing the serrated joints are replaced. Under high-load conditions, reuse of the fixator should be discouraged. Fixator pins should not be reused regardless of the application conditions.

The low-load high-cycle test results could be used to provide guidelines for fixator reusability under normal clinical application. The high-load low-cycle test provides information on which parts of the fixator are vulnerable to fatigue failure and they should be replaced when reuse is being considered. These tests are necessary to assess the reusability of a well-made and highly versatile external fixator based on biomechanical considerations and cost containment issues. 5

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