The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 86, Issue 5

Scientific Articles | May 01, 2004

Backside Wear of Modular Ultra-High Molecular Weight Polyethylene Tibial Inserts

Michael A. Conditt, PhD¹; Sabir K. Ismaily, BS¹; Jerry W. Alexander, BS¹; Philip C. Noble, PhD²

¹ Institute of Orthopedic Research and Education, 6550 Fannin Street, Suite 2512, Houston, TX 77030. E-mail address for M.A. Conditt: mconditt@bcm.tmc.edu
² Barnhart Department of Orthopedic Surgery, Baylor College of Medicine, 6550 Fannin Street, Suite 2625, Houston, TX 77030

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The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Investigation performed at the Institute of Orthopedic Research and Education, Houston, Texas

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2004 May 01;86(5):1031-1037

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Abstract

Background: The capture mechanisms of modular tibial total knee components may allow relative micromotion between the insert and the base-plate, leading to wear at the nonarticulating (backside) surface. Although retrieved components often display laxity in the capture mechanism in the unloaded condition, the magnitude of the relative motion that actually occurs under physiologic conditions has not been determined. This study was performed to assess the impact of different modes of knee-loading on the relative micromotion between the insert and the base-plate and the relationship between the duration that the implant had been in situ and the severity of backside wear.

Methods: Twenty-one posterior-stabilized total knee replacements of one common design (Insall-Burstein II) were retrieved at one to 100 months after implantation. The extent and severity of backside wear was graded with use of stereomicroscopy. All components were soaked in a bath (of physiologic saline solution at 37°C for four days prior to reassembly. The relative micromotion between the insert and the base-plate of each specimen was measured in vitro in two different conditions: with no axial load and with a combination of loads and torques simulating the stance phase of gait.

Results: The capture mechanism laxity between the insert and the tibial base-plate in the unloaded condition was approximately eight times larger than the micromotion measured during simulated gait. The capture mechanism laxity allowed a mean (and standard deviation) of 618 ± 226 µm of total relative micromotion compared with 103 ± 54 µm of relative micromotion during the gait cycle. Under both loading conditions, the predominant direction of interface motion was medial-lateral. No correlation was found between the magnitude of capture mechanism laxity and the relative micromotion measured during simulated gait (p = 0.11). Larger polyethylene protrusions on the backside surface did not correlate with less micromotion (p = 0.48) or with capture mechanism laxity (p = 0.06).

Conclusions: For the implant design that was studied, capture mechanism laxity between the modular insert and the base-plate in the unloaded condition was an order of magnitude larger than and not indicative of the micromotion that occurred during simulated physiologic loading. In addition, polyethylene protrusions into the screw-holes of tibial base-plates did not seat or lock the insert in place and reduce relative motion.

Clinical Relevance: While some clearance between the insert and the base-plate is required to allow assembly of modular tibial components at the time of surgery, the amount of relative interface motion during a functional activity such as normal gait, which can produce potentially damaging wear debris, is unknown. However, the compressive forces applied to the articular surface during a functional activity may substantially reduce micromotion between the insert and the base-plate relative to the unloaded condition.

Figures in this Article

The tibial component of a total knee replacement may be an all ultra-high molecular weight polyethylene piece (hereafter referred to as polyethylene), a monolithic metal-polyethylene nonmodular composite part, or a modular combination of a metal tibial base-plate and a polyethylene insert. Finite element analysis has shown that metal-backed components improve fixation by reducing the stress at the bone-implant interface^1-4. Modular designs, with separate metal tibial base-plates and polyethylene inserts, allow the surgeon to select the bearing surface on the basis of the size of the femoral component that best matches the femur, independent of the size or the design of the tibial base-plate⁵. A modular design also can reduce the complexity of a revision by allowing the exchange of worn polyethylene components without extraction of the tibial base-plate, thereby avoiding disruption of the bone-prosthesis and cement-prosthesis interfaces.

Despite these advantages, the use of modular tibial components introduces an additional site of potential relative motion between the base-plate and the insert. Recent studies have shown that retrieved polyethylene tibial inserts exhibit wear patterns on the nonarticulating (backside) surface independent of the design of the capture mechanism^6-15. This site may be a source of clinically important polyethylene debris, leading ultimately to osteolysis and implant failure^{7,8,11,14,16-20}. While micromotion between the polyethylene insert and the metal tibial base-plate is assumed to be the cause of backside wear, the relationship between the magnitude of micromotion during physiologic loading and the type and severity of material loss at this interface is unknown.

One approach to reduce interface motion and generation of wear debris has been to improve the design of the capture mechanism between the base-plate and the insert. By definition, modularity in the tibial component requires some amount of clearance at the interface of the insert and the baseplate to allow assembly and disassembly at the time of surgery. Looseness, or laxity, as evidenced by relative motion between the insert and the base-plate in the unloaded condition thus may occur. Several authors have proposed a laboratory method for the measurement of locking-mechanism laxity under unloaded conditions and have suggested that this measurement is a valid indicator of the severity of backside wear^21-23. However, it is not known how much of this motion remains when the component is loaded, potentially leading to the generation of polyethylene debris by backside wear.

In an earlier study¹⁵, we examined the prevalence and severity of wear and surface deformation of the backside surface of 124 tibial inserts retrieved after an average period of implantation of fifty-one months (range, zero to 180 months). The twelve different designs included in that study showed abrasive wear and deformation over the backside surface in varying degrees of severity, which was dependent on the design of the articulation, the capture mechanism, and the time that the implant had been in situ. The present study examined the effects of micromotion, capture mechanism laxity, and the duration of implantation on backside wear through a biomechanical investigation of twenty-one components of one design selected from our population of retrieved implants. These experiments were conducted to assess (1) the impact of different modes of knee-loading on relative micromotion between the insert and the base-plate, and (2) whether capture mechanism laxity between the insert and the tibial base-plate, as observed in the operating room, is a valid predictor of micromotion during the gait cycle and of the severity of backside wear while the implant is in situ.

Materials and Methods

Materials and Methods | Results | Discussion | References

Twenty-one posterior-stabilized total knee replacements of one common design (Insall-Burstein II; Zimmer, Warsaw, Indiana) were retrieved at revision total knee arthroplasty at an average of forty-seven months (range, one to 100 months) after implantation. The components were retrieved from twenty-one patients (ten women and eleven men) with an average age of sixty-four years (range, thirty-four to eighty-three years) at the time of the revision. The patient group had an average weight (and standard deviation) of 924.8 ± 162.8 N (range, 631.6 to 1242.0 N) and an average height of 1.76 ± 0.11 m (range, 1.52 to 1.91 m). The reasons for the revision included loosening (fourteen knees), infection (four), malalignment (one), fracture (one), and patellar complications (one).

The capture mechanism of this design is a medial-lateral dovetail slide with a locking pin. Each insert was visually inspected under stereomicroscopy (×32). For evaluation of surface damage, the backside was divided into four quadrants: anteromedial, anterolateral, posterolateral, and posteromedial. Within each quadrant, the severity of burnishing, pitting, embedded acrylic debris, scratching, abrasion, delamination, and surface deformation was assessed with use of a system similar to that proposed by Hood et al.²⁴. All damage modes were given a score of 0 to 10 on the basis of either the area of the surface affected by burnishing, pitting, embedded debris, and abrasion or the severity of that particular wear pattern (delamination, scratching, and surface deformation)¹⁵.

The tibial base-plate of this design is a titanium alloy with a grit-blasted, so-called satin-finish, surface with four holes for fixation screws. Protrusions of polyethylene, extending from the backside surface of the insert into the holes within the base-plate, were often observed. To measure the height of the protrusions, the backside surface of each retrieved implant was scanned with a laser surface profilometer (Cyberware, Monterey, California). Multiple linear and cylindrical scans of each insert were aligned and merged with each individual scan, having a resolution of 0.1 mm in the plane of the scan and a resolution of 0.008 mm in depth. This process resulted in approximately 100,000 three-dimensional points defining the backside surface. With use of CAD (computer-aided design) software (UniGraphics; EDS, Plano, Texas), individual three-dimensional surface models of each retrieved insert were developed. The height of each protrusion above the backside surface was calculated with use of the following method. First, the backside surface surrounding the protrusion was defined by calculating the plane of best fit to all data points collected from an anular area, 1 cm wide, extending 0.5 mm from the edge of the protrusion. The top of each protruding peg was defined as the entire area 0.5 mm in from the edge of the protrusion. Exclusion of this 1-mm anulus excluded the transition from the surrounding backside surface and the surface of the protrusion. This allowed the calculation of the height of each polyethylene protrusion by the average distance between the points defining its top surface and the backside of the insert.

Capture Mechanism Laxity

The capture mechanism laxity of the assembled modular components in the unloaded condition was measured after soaking all components in a bath of physiologic saline solution at 37°C for four days²⁵. Each insert and its matching base-plate were reassembled and mounted in a materials testing machine (MTS, Minneapolis, Minnesota) with use of a custom fixture (Fig. 1-A). Each assembly was positioned such that the tray-insert interface was oriented vertically, and the loading was applied according to the protocol described by Engh et al.^21-23. Shear loads of ±200 N were applied to the insert in both the medial-lateral and the anterior-posterior direction sequentially (Fig. 1-B). Displacement response curves from preliminary studies indicated that a load of 200 N was sufficient to overcome friction and allowed the insert to move within the capture mechanism to its mechanical stop without substantial deformation of the polyethylene. The loading profile in each direction was repeated an additional cycle to ensure reproducibility²². During loading, relative motion between the tray and the insert was recorded with linear variable displacement transducers (resolution, 1 µm; Duncan Electronics, Tustin, California). A so-called peak-to-peak excursion was measured in the two directions, which corresponded to the maximum excursion of the insert in that direction during one loading cycle. The total laxity in the locking mechanism was defined as the square root of the sum of the squares of the mediolateral and anteroposterior displacement in the locking mechanism of each insert, recorded during application of the reversed shear load. This has been referred to as the insert-motion index in previous studies^22,23. The components were tested in air at room temperature.

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Fig. 1-A: Mechanical setup to measure relative micromotion between the insert and the base-plate in air with no axial load or rotational torque.

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Fig. 1-B: Anterior-posterior and medial-lateral load applied to the insert while the base-plate was rigidly fixed.

Backside Micromotion During Physiologic Loading

The insert, base-plate, and femoral component were reassembled and loaded in a single-station knee-joint simulator, which flexed the femoral component over a range of 0° to 40° with a motor and linkage assembly (Fig. 2-A). During the flexion cycle, a time-varying axial compressive force was applied to the tibia, corresponding to the dynamic forces experienced during the stance phase of gait, with a peak of 1900 N²⁶. The line of action of the axial force was offset medially from the centerline of the insert by a distance corresponding to 7% of the overall width of the tibial component²⁷. Axial torque, ranging from 6 N-m internally to 4 N-m externally, was also applied to the tibial component in phase with the axial load with use of a profile simulating torques developed during the stance phase of gait (Fig. 2-B)²⁸. Both the axial load and the internal-external torques were applied with use of load control. All loading experiments were performed at body temperature (37°C), in a temperature-controlled bath of physiologic saline solution. During loading, the anterior-posterior and medial-lateral components of translation and the transverse rotation of the insert with respect to the metal base-plate were measured with use of an array of three noncontacting displacement transducers (resolution, 2 µm; Shaevitz Engineering, Pennsauken, New Jersey) monitored with a sixteen-bit analog-digital board. Each set of assembled components experienced fifty gait cycles, with the last twenty cycles averaged at each flexion angle. A peak-to-peak excursion was measured from the averaged motion in the two directions, which corresponded to the maximum excursion of the insert in that direction during one loading cycle.

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Fig. 2-A: Mechanical setup to measure relative micromotion between the insert and the base-plate in a physiological saline-solution bath at 37°C with time-varying load and torque applied to the tibia while the femur was flexed and extended, simulating the stance phase of gait.

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Fig. 2-B: Axial load and rotation torque applied to the tibia. I/E = internal-external.

Statistical Analysis

The Student t test and the Pearson correlation coefficient with the Fisher r to z transformation analyses were performed to determine the significance of differences between capture mechanism laxity and micromotion measured during simulated gait. Significance was set at p < 0.05.

Results

Materials and Methods | Results | Discussion | References

Of the seven modes of surface damage evaluated, only three were observed on the nonarticulating backside surface of the retrieved inserts. Burnishing was noted on the backside surface of almost all components (95%). Pitting was also common (81% of the tibial inserts). In sixteen (76%) of the twenty-one inserts, cylindrical pegs protruded from the undersurface of the polyethylene insert into screw-holes within the tibial backing plate. On a scale from 0 to 10, the average pitting score (and standard deviation) for the entire backside was 2.1 ± 2.1 (range, 0 to 7.25), and the average burnishing score was 4.3 ± 2.9 (range, 0 to 9). Sixteen components (76%) exhibited measurable polyethylene protrusions into at least one of the holes within the base-plate, with an average protrusion height of 51 ± 75 µm (range, 0 to 350 µm) above the surrounding surface. The tallest protrusions involved the posteromedial and anterolateral screw-holes (average protrusion heights, 70 ± 84 µm and 70 ± 88 µm, respectively; Table I).

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TABLE I Data on the Surface Wear

Mode of Wear	Rate of Occurrence (% of Inserts)	Measurement*
Medial backside burnishing†	95	5.1 ± 3.1 (0-9)
Lateral backside burnishing†	95	4.0 ± 3.0 (0-9)
Medial backside pitting†	81	2.3 ± 2.4 (0-7.5)
Lateral backside pitting†	76	2.2 ± 2.3 (0-8)
Anteromedial protrusion (µm)	72	48 ± 86 (0-350)
Posteromedial protrusion (µm)	72	70 ± 84 (0-290)
Anterolateral protrusion (µm)	57	70 ± 88 (0-280)
Posterolateral protrusion (µm)	57	34 ± 78 (0-310)

The values are given as the average and the standard deviation, with the range in parentheses. †Damage modes were given a score of 0 to 10 on the basis of the area of the surface affected by burnishing or pitting.

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TABLE I Data on the Surface Wear

Mode of Wear	Rate of Occurrence (% of Inserts)	Measurement*
Medial backside burnishing†	95	5.1 ± 3.1 (0-9)
Lateral backside burnishing†	95	4.0 ± 3.0 (0-9)
Medial backside pitting†	81	2.3 ± 2.4 (0-7.5)
Lateral backside pitting†	76	2.2 ± 2.3 (0-8)
Anteromedial protrusion (µm)	72	48 ± 86 (0-350)
Posteromedial protrusion (µm)	72	70 ± 84 (0-290)
Anterolateral protrusion (µm)	57	70 ± 88 (0-280)
Posterolateral protrusion (µm)	57	34 ± 78 (0-310)

In the unloaded condition, the capture mechanism laxity at the interface of the polyethylene insert and the base-plate was an average (standard deviation) of 555 ± 185 µm in the medial-lateral direction and 195 ± 234 µm in the anterior-posterior direction, corresponding to a ratio of 2.8 to 1.0 (Fig. 3). During laboratory simulation of physiologic loading, the predominant motion of the insert relative to the tibial tray was also medial-lateral sliding, with an average peak-to-peak excursion of 93 ± 56 µm (45 µm laterally and 48 µm medially). Motion also occurred in the anterior-posterior direction with an average peak-to-peak excursion of 38 ± 23 µm (13 µm posteriorly and 25 µm anteriorly) (Fig. 3). The total amount of medial-lateral micromotion averaged 2.9 times the amount of anterior-posterior micromotion. During the gait cycle, the insert began laterally and posteriorly translating while also internally rotating relative to the tibial tray. During the period of the gait cycle from midstance to toe-off, the insert experienced a large reversal in the direction of translation from lateral to medial and from posterior to anterior and of rotation from internal to external (Fig. 4). Surprisingly, under physiologic loading, the insert also rotated in the transverse plane an average of 153 ± 109 millidegrees (64 millidegrees externally and 89 millidegrees internally), in phase with the applied cyclic moment applied to the articulating (tibiofemoral) interface.

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Fig. 3: Medial-lateral (ML) and anterior-posterior (AP) motion during physiologic loading and inherent in the capture mechanism.

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Fig. 4: Typical insert motion relative to the tibial base-plate during the gait cycle.

The capture mechanism insert-motion index (618 ± 226 µm) exceeded the insert-motion index observed during simulated gait (103 ± 54 µm) by an average factor of 7.7. There was no correlation suggesting that backside micromotion during physiologic loading increased with capture mechanism laxity (r² = 0.14, p = 0.11) (Fig. 5). Many specimens displayed similar micromotion (70 to 100 µm) under physiologic conditions, despite large variations in the capture mechanism laxity (300 to 1100 µm). Neither laxity nor micromotion during simulated gait increased with the duration that the implant had been in situ (p = 0.70 and p = 0.99, respectively). Some components exhibited substantial relative micromotion between the insert and the base-plate despite the relatively short times in situ (Fig. 6).

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Fig. 5: Relationship between capture mechanism laxity and micromotion during a functional activity (gait). Motions are total motions, i.e., the square root of the sum of the squares of the medial-lateral and anterior-posterior motions.

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Fig. 6: Comparison of the temporal progression of capture mechanism laxity and relative micromotion with the time that the implants had been in situ.

There was no correlation between the magnitude of micromotion during simulated gait and the severity of burnishing (p = 0.97) or pitting (p = 0.16). However, a significant correlation was observed between capture mechanism laxity and the severity of pitting (p < 0.05) but not between capture mechanism laxity and burnishing (p = 0.51). The height of the polyethylene protrusions on the backside surface did not correlate with micromotion during physiologic loading (p = 0.48) or with capture mechanism laxity (p = 0.06).

Discussion

Materials and Methods | Results | Discussion | References

Our results indicate that, in modular tibial components, the micromotion occurring between the tibial tray and the polyethylene insert during a simulated gait cycle is not directly related to the laxity within the locking mechanism observed in the unloaded condition. Moreover, the magnitude of motion generated by in vivo loading conditions is an order of magnitude smaller than the motion measured in the unloaded state. In this study, it seems that, in the absence of axial compressive loads, translational forces caused the insert to move to the extent permitted by the clearance within the capture mechanism. However, once an axial component of joint loading was applied, the mechanical response at the interface appears to have been dominated by the area and distribution of contact and the coefficient of friction at the insert-base-plate interface. On the basis of these results, we suggest that the magnitude and direction of relative motion between the insert and the tibial tray during in vivo use is a complex function of the multiaxial dynamic loading of the components and the design of the capture mechanism. Another potential effect of compressive loading of the polyethylene is expansion of the insert in the transverse plane in response to axial compression (the Poisson effect), which may reduce or even eliminate any clearance present in the capture mechanism prior to loading. The amount of this deformation is difficult to predict, as the distribution of forces and moments applied to the insert both in vivo and in the physiologic loading experiment are by means of the articulating counterfaces. The resulting deformation is also a function of the points of application of the joint load, which are determined by the design of the articular surfaces and the kinematics of joint motion.

In this study, the tibial inserts exhibited a large reversal in the direction of movement relative to the tibial tray from medial to lateral at midstance to toe-off. This was likely due to the coupling of the off-axis axial load and the change in the direction of the rotational torque from internal to external at midstance. The design tested uses a linear medial-lateral tongue-and-groove capture mechanism with a locking pin inserted anteriorly to prevent medial-lateral motion. Nevertheless, during the simulated stance phase of gait, we measured transverse plane translation and rotation. This is particularly surprising as this is a relatively low-demand functional activity.

Our data showed that neither motion between the insert and base-plate nor capture mechanism laxity correlated with the duration that the component had been in situ. In fact, large intercomponent micromotion, both with laxity and under simulated gait, was observed in implants with a short duration in situ. Two components, both of which had been in situ for one month, exhibited average or above average laxity and physiologically loaded micromotion (Fig. 6). This finding is not in agreement with the explanation that capture mechanisms become more "sloppy" with the longer time that an implant is in situ²². In a study of the stability of capture mechanisms, Engh et al.²² measured the capture mechanism laxity of fifteen components retrieved at revision arthroplasty, fifteen components retrieved at autopsy, and ten new components. While that study did not describe the relationship between the time that the implants had been in situ and the stability of the locking mechanism for the retrieval group specifically (revision and autopsy), significantly more motion was noted for retrieved components than for unimplanted components (p < 0.001). As we did not test new components, we can only note the large variability in the measurements of motion that we observed across all retrievals, seemingly independent of the duration that the implants had been in situ. Considered together, our data and the data of Engh et al.²² indicate that a minimum number of loaded cycles may be required to deteriorate the inherent stability of a capture mechanism. It is not clear that the relative micromotion between the insert and the base-plate increases only as a function of the time that the implant is in situ; the magnitude may depend on a complex combination of variables.

Designers of past generations of modular tibial components likely did not anticipate relative insert-base-plate motion. The surface roughness of grit-blasted, satin-finish tibial trays has been measured to be 2.97 to 5.54 µm²⁹. The satin finish on the titanium-alloy trays in the current study may wear the backside of a polyethylene insert with repeated motion more severely than would a more polished base-plate. In fact, the results of our study showed that even implants with relatively short implantation times exhibit severe burnishing. This burnishing could potentially lead to a continuous release of wear debris.

A form of polyethylene cold flow that some investigators have suggested may contribute to the stabilization of the bearing insert is extrusion of polyethylene into the screw-holes of the tibial base-plate^7,12,13,15. It has been observed that retrieved tibial inserts often exhibit raised protrusions on the backside surface at sites opposite screw-holes within the base-plate. It can be postulated that protrusions of polyethylene into the holes may in fact lock the insert in place, reducing relative motion with time. In the present study, many of the retrieved inserts had polyethylene protrusions on the backside surface, ranging in height from 0 to 350 µm with respect to the surrounding surface. However, we found no correlation between either the size or the presence of these protrusions and the magnitude of capture mechanism laxity or micromotion generated during simulated physiologic loading.

In this study of one modular tibial component design with a polyethylene insert and metal base-plate, we measured the relative motion between the tibial base-plate and the insert during simulated physiologic motion. We also measured the relative motion inherent in the capture mechanism. It remains unclear whether it is more detrimental to have small relative motions with high compressive forces or much larger motions with much smaller forces. Minimizing insert micromotion should be a criterion in new designs of modular tibial components to minimize the generation of polyethylene wear debris at the nonarticulating surface.

References

Materials and Methods | Results | Discussion | References

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Topics

gait ; bone plates ; tibia ; torque ; polyethylene ; saline solution ; ultra-high molecular weight polyethylene ; tibial insert

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Michael A. Conditt, Sabir K. Ismaily, Jerry W. Alexander, Philip C. Noble; Backside Wear of Modular Ultra-High Molecular Weight Polyethylene Tibial Inserts. The Journal of Bone & Joint Surgery. 2004 May;86(5):1031-1037.

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