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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 49 - 49
10 Feb 2023
Erian C Erian M Ektas N Scholes C Bell C
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Anterior cruciate ligament (ACL) ruptures are debilitating injuries, often managed via ACL reconstruction (ACLR). Reduced range of motion (ROM), particularly loss of extension (LOE), is the most significant contributor to post-operative patient dissatisfaction. LOE may preclude return to sport, increase re-rupture rates and precipitate osteoarthritis.

Passive LOE rates following ACLR have been reported at 15%. However, LOE incidence during active tasks are poorly characterised. Our review sought to determine knee extension angles for active tasks following an ACL injury or ACLR. We hypothesised greater incidences of active LOE following ACL injury or ACLR, compared to uninjured contralateral limbs or controls.

We systematically searched MEDLINE, Embase, Cochrane Library, Scopus, SPORTDiscus, and relevant trials databases for English articles. Included were cohort, cross-sectional, case-controlled or randomised controlled trials analysing adults with ACL injury treated surgically or otherwise, with at least 12-weeks follow-up and reporting either active knee extension angle, active LOE angles or incidence of active knee LOE during functional tasks. The protocol was registered on PROSPERO (CRD42018092295). Subsequent meta-analysis was performed.

After screening, 71 eligible articles were included. Studies were heterogenous in design and quality. Included tasks were overground walking (n=44), running (n=3), hopping/jumping/cutting (n=11) single-leg landing (n=7), and stair climbing (n=6). LOE incidence varied depending on functional activities (33.95-92.74%). LOE incidence did not vary depending on ACL status (67.26% vs. 65.90% vs. 62.57% for ACL intact, ACLD and ACLR, respectively).

We observed no difference in active LOE incidence according to ACL status. Importantly, the observed incidence for active LOE was reliably higher than previously reported rates for passive measures.

Given the discrepancy between active and passive LOE incidence, clinicians may advisably prioritise active ROM during ACL rehabilitation.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 118 - 118
1 May 2016
Walker P Arno S Borukhov I Bell C Salvadore G
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Introduction

The major function of the medial meniscus has been shown to be distribution of the load with reduction of cartilage stresses, while its role in AP stability has been found to be secondary. However several recent studies have shown that cartilage loss in OA occurs in the central region of the tibia while the meniscus is displaced medially. In a lab study (Arno, Hadley 2013) it was confirmed that the AP laxity was greatly reduced with a compressive force across the knee, while the femur shifted posteriorly and the AP laxity was increased after a partial meniscetomy of the posterior horn. It is therefore possible that under load, the compression of the meniscus and the cartilage, 2–3mm in total, allows load transmission on the central tibial plateau, and causes radial expansion and tension of the meniscus providing restraint to femoral displacements. This leads to our hypotheses that the highest loading on the medial meniscus would be at the extremes of motion, rather than in the mid-range, and that the meniscus would provide the majority of the restraint to anterior-posterior femoral displacements throughout flexion when compressive loads were acting.

Methods & Materials

MRI scans were taken of ten knee specimens to verify the absence of pathology and produce computer models. The knees were loaded in combinations of compressive and shear loading over a full flexion range. Tekscan sensors were used to measure the pressure distribution across the joint as the knee was flexed continuously. A digital camera was used to track the motion, from which femoral-tibial contacts were determined by computer modelling. Load transmission was determined from the Tekscan for the anterior horn, central body, posterior horn, and the uncovered cartilage in the center of the meniscus. An analysis was carried out (Fig 2) to determine the net anterior or posterior shear force carried by the meniscus.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 120 - 120
1 May 2016
Walker P Meere P Borukhov I Bell C
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PURPOSE

Soft tissue balancing can be achieved by using spacer blocks, by distractors which measure tensile forces, or by instrumented devices which measure the forces on the lateral and medial condyles. However there is no quantitative method for assessment of balancing at clinical follow-up; to address this, we developed a Smart Knee Fixture (SKF) which measured the varus and valgus angles for a moment of 10 Nm. Our purpose was to determine if varus and valgus angles measured at clinical follow-up, was equivalent to the balancing parameters of distraction forces or contact forces measured at surgery.

METHODS

The SKF, which measured VV angles using stretch sensors on each side of the knee, was validated by cadaver studies, fluoroscopy, and emg. The balancing parameters were:

The lateral and medial contact forces at surgery, expressed as FL/FM

The distraction tensions in the collateral ligaments at surgery, expressed as TL/TM

The moments to cause lift-off when a varus or valgus moment is applied, MVAR/MVAL

The varus and valgus angles measured at post-op follow-up, VAR/VAL

A force analysis, and measurements on 101 surgical cases & clinical follow-up in an IRB study, were carried out to determine the relationship between these parameters.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 116 - 116
1 May 2016
Walker P Meere P Borukhov I Bell C
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PURPOSE

Soft tissue balancing can be achieved by using spacer blocks, by distractors which measure tensile forces, or by instrumented devices which measure the forces on the lateral and medial condyles. However there is no quantitative method for assessment of balancing at clinical follow-up; to address this, we developed a Smart Knee Fixture (SKF) which measured the varus and valgus angles for a moment of 10 Nm. Our purpose was to determine if varus and valgus angles measured at clinical follow-up, was equivalent to the balancing parameters of distraction forces or contact forces measured at surgery. METHODS: The SKF, which measured VV angles using stretch sensors on each side of the knee, was validated by cadaver studies, fluoroscopy, and emg. The balancing parameters were:

The lateral and medial contact forces at surgery, expressed as FL/FM

The distraction tensions in the collateral ligaments at surgery, expressed as TL/TM

The moments to cause lift-off when a varus or valgus moment is applied, MVAR/MVAL

The varus and valgus angles measured at post-op follow-up, VAR/VAL

A force analysis, and measurements on 101 surgical cases & clinical follow-up in an IRB study, were carried out to determine the relationship between these parameters.

RESULTS

The ratio TL/TM was approx. equal to FL/FM, especially near to a balanced state

The ratio MVAR/MVAL (lift-off moments) was equal to FL/FM

The ratio VAR/VAL was approx. equal to FL/FM only if the collateral stiffnesses were equal;

otherwise the ratio was approx. proportional to the collateral stiffnesses.

In the clinical follow-ups, there was no significant linear relation between VAR/VAL and FL/FM.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 35 - 35
1 Jan 2016
Bell C Meere P Borukhov I Walker P
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Introduction

Evaluation of post-operative soft tissue balancing outcomes after Total Knee Arthroplasty (TKA) and other procedures can be measured by stability tests, with Anterior-Posterior (AP) drawer tests and Varus-Valgus (VV) ligamentous laxity tests being particularly important. AP stability can be quantified using a KT1000 device; however there is no standard way of measuring VV stability. The VV test relies on subjective force application and perception of laxity. Therefore we sought to develop and validate a device and method for quantifying knee balancing by analyzing VV stability.

Materials and Methods

Our team developed a Smart Knee Fixture to measure VV angular changes using two dielectric elastomer stretch sensors, placed strategically over the medial and lateral collateral ligaments (see Figure 1). The brace is secured in position with the leg in full extension and the sensors locked with pre-tension. Therefore, contraction and elongation of either sensor is measured and the VV angular deviation of the long axis of the femur relative to that of the tibia is derived and displayed in real time using custom software. EMG muscle activity was previously investigated to confirm there is no resistive activity during the VV test obstructing ligamentous evaluations.

The device was validated in two ways:

A bilateral lower body cadaver specimen, secured in a custom test rig, was used to compare the Smart Knee Fixture's readings to those measured from an optical surgical navigation system. Abduction and adduction force was gradually applied as varus and valgus moments with a wireless hand-held dynamometer up to 50N (19.8Nm) at 0 and 15° flexion.

Two male volunteers were used to compare the Smart Knee Fixture's readings to those measured from fluoroscopic images. An arthroscopic distal thigh leg immobilizer was used to prevent rotation and lateral movements of the thigh when moments were applied at the malleoli. A C-arm Fluoroscope was then positioned focusing on the center of the joint. The tests were performed at full extension, 10 and 20° of flexion and force was gradually applied to 50N.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 36 - 36
1 Jan 2016
Bell C Meere P Borukhov I Rathod P Walker P
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The use of smart trial components is now allowing a better assessment of soft tissue balancing at the time of total knee replacement surgery. A balanced knee can be defined as one that possesses symmetry, ie. equal and centered lateral and medial forces through the full range of flexion. There is still a need for a standard reproducible surgical test to quickly confirm optimized balancing at surgery with such devices. The Heel Push test is the established standard, by pushing the foot in a cephalad direction while supporting the thigh and keeping the leg stable in the vertical plane. A common variation of this test is the Thigh Pull test where the foot is actively assisted during the cephalad pull of the thigh through deep flexion. The test is an open chain test. The Thigh Pull test may be an improvement since the weight of the leg is alleviated and no supplemental compressive forces are introduced. The directional changes of the lower extremity are thus a result of ligamentous tension and balances. The purpose of this study is to compare the two tests using a standard testing methodology and observe the variation in kinetic parameters in a controlled biomechanical setting.

A custom l rig was developed, which independently controls all six degrees of freedom about the knee joint. In addition a commercial navigation system was used to derive instantaneous alignment values and flexion angles between the tibia and femur. The pelvis was fixed to the table and the foot was fitted onto a low friction carriage along a slide rail. The knee design used was cruciate retaining. The pressure mapping system was a wireless tibial trial that provided magnitude of load per compartment.

The study is a preliminary cadaveric study reporting the data from two. In this experiment the leg was then tested with the Heel Push and Thigh Pull tests after obtaining optimum soft tissue balance of the cadaveric specimen. From this standard neutral state a series of single surgical variables were introduced to mimic common intra-operative surgical corrections. This was achieved through custom tibial liner and angle shims.

The results defied theoretical anticipation. Though the total contact forces with heel push were generally higher than with thigh pull, the relative load distribution between compartments did not follow a trend (see Figure 1). Furthermore in deeper flexion the persistence of relatively high contact pressures would suggest that ligaments still generate intra-articular forces despite the much weaker gravitational effect. The clinical relevance lies in the asymmetry of the load distribution between medial and lateral compartment for the two methods tested. The load asymmetry as tested by the Thigh Pull test may correspond to an open chain in swing phase. This asymmetry would force some axial rotation and tibial femoral alignment deviation that can significantly affect the forces at the time of heel strike. The Heel Push test would be more representative of the compressive forces in a closed chain mode as seen during the stance phase of gait.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 34 - 34
1 Jan 2016
Bell C Meere P Borukhov I Rathod P Walker P
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Soft tissue balancing in total knee replacement may well be the determining factor in raising the fair patient satisfaction. The development of intelligent implants allows quantification of reactive loads to applied pressures. This can be tested in dynamic mode such as heel push test at surgery, or in static mode such as when testing for varus/valgus (VV) laxity of the collateral ligaments of the knee. We postulate that a well-balanced knee will have comparable if not equal load distribution across compartments in dynamic loading. When tested for laxity, we anticipate an equal or comparable response to VV applied loads under physiologic load range of 10–50N. This study sought to analyze the relationship between the kinematic (joint motion) and kinetic (force) effects to VV testing in the 0–15 degrees range of flexion. One goal was to demonstrate that testing the knee in locked extension (Screw Home effect) is unreliable and should be abandoned in favor of the more reliable VV testing at 10–15 degrees of flexion.

This is a preliminary cadaveric study utilizing data from two hemibodies. The pelvis was fixed in a custom test rig with open or closed chain lower leg testing capability along a sliding rail with foot VV translational. Forces were applied at the malleoli with a wireless hand held dynamometer. Kinematic analysis of the hip-knee-ankle (HKA) tibiofemoral angle was derived from a commercial navigation system with mounted infrared trackers. Kinetic analysis was derived from a commercially available sensor imbedded in a tibial trial liner. Balance was optimized by conventional methods with the use of the sensor feedback until loads were roughly symmetrical and VV testing yielded symmetrical rise in opposite compartments. The VV testing was then performed with the knees locked at the femoral side in axial rotation and translational motion in any plane. Sagittal flexion was pre-set at 0, 10, and 15 degrees and progressive load was applied.

Results

From the graphs one can observe significant differences between VV testing at 0 degrees (locked Screw Home), 10 degrees, and 15 degrees of flexion. The shaded area corresponds to the common range of VV stress testing loading pressure, typically less than 35N. The HKA deviates from neutrality no sooner than by the middle of the physiologic test zone. By 35N, the magnitude of the effect is also much less than that observed at 10 and 15 degrees (unlocked from Screw Home). From the kinetic analysis one can also note the significant difference in the High-Low spread throughout the testing range of applied pressure.

If the surgeon tests in the low range of applied loads, he/she may not observe the kinematic joint opening effect. The kinetic effect seems more reliable as sensed loads are detectable earlier on. It is clear however that testing at 10–15 degrees offers a much better sensitivity to the VV laxity or stiffness as exemplified in the bottom portions of the figure. Therefore testing in locked Screw Home full extension may lead to underestimation of the true coronal laxity of the joint.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 109 - 109
1 Jan 2016
Walker P Meere P Bell C
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There are many different approaches to achieving balancing in total knee surgery. The most frequently used method is to obtain correctly aligned bone cuts, and then carry out necessary soft tissue releases to achieve equal flexion and extension gaps. In some techniques, the bone cuts themselves are determined by the prevailing soft tissue status or the kinematics during flexion-extension. Navigation can provide quantitative data during these processes but so far, navigation is used in only in a minority of cases. However in recent years, new technologies have been introduced with lower cost and implementation time, allowing for more widespread use. Early studies have indicated that more reproducible balancing can be obtained, and that balancing has a positive effect on clinical outcomes. However the ability to measure balancing quantitatively during surgery, has raised the questions of the most systematic method for implementation during surgery, and the relative influence of various correcting factors. Further, the ideal balancing parameters with respect to varus-valgus ratios and the magnitudes during a full flexion range, have yet to be defined. Even if normative data is the target, there is scant data on this topic.

In our own laboratory, we carried out experiments on knee specimens where the various surgical variables were systematically investigated for their effect on varus-valgus balancing. Different tests were developed including the ‘Heel Push Test’ where lateral and medial contact forces were plotted as a function of flexion. Imbalances were achieved with either bone cut adjustments or soft tissue releases. The major finding was that adjustments of only 2 mms or 2 degrees could correct most imbalances. This was considered to be due to two effects; the pretension in the ligaments bringing the structure to the stiff part of the load-elongation curve, and the high values of the stiffness itself. Medial-lateral equality was the goal in this work, but recognizing that this may not be the situation in the normal knee. To answer this question, we developed a method for measuring the varus-valgus balancing in normal subjects, using a ‘Smart Knee Fixture’ with embedded stretch sensors. We validated this device using cadaveric specimens, and normal volunteers using fluoroscopy and electromyography. We are now applying the method in an IRB study to both normals and post-operative knee replacement cases. For the latter, the relation between operative data, and post-operative balancing will be studied, as well as the relation of balancing to functional outcomes.

This overall subject of balancing at surgery, and the post-operative effects, is open to extensive experimental research, and is predicted to result in improved outcomes.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 110 - 110
1 Jan 2016
Walker P Lowry M Arno S Borukhov I Bell C
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Total Knee Arthroplasty (TKA), has now become a reliable, successful, and widely used treatment for osteoarthritis. Numerous reports indicate that for the majority of patients, the TKA lasts a lifetime with pain relief and the ability to perform most everyday activities. However there are a number of ways in which the procedure can be further improved, the focus here being on function. One of the problems in evaluating function is that it depends upon the inherent ability, motivation, and expectation of the patients. There are several well-used questionnaire systems which capture functional ability objectively. In the effort to simplify evaluation, a ‘forgotten knee’ evaluation has been introduced, the concept being that ‘the ideal TKA design’ would feel and function like a normal knee. Such a measure would include factors such as surgical technique, alignment, and rehabilitation, as well as the TKA design itself. Another approach to evaluation is to measure biomechanical parameters, such as in gait analysis and fluoroscopy, which evaluate kinematic or kinematic parameters, using normal controls for comparison. Nevertheless, such evaluations still include factors other than the TKA design itself, and do not apply to new designs.

The approach taken here for the evaluation of a new TKA design independent of other factors, is to measure the neutral path of motion and the laxity boundaries of the loaded knee on the application of shear and torque over a full range of flexion. The benchmark is the same kinematic data from the normal intact knee. The rationale has some analogy to the ‘forgotten knee’ in that if the laxity response of a design of TKA is the same as that of the anatomic knee itself, the behavior of that implanted knee in any functional condition will be indistinguishable from that of the anatomic knee itself. Such a testing concept has some similarities to the constraint test described in the ASTM standard. In this paper, a novel design algorithm is proposed for creating different design concepts. First, a general morphological form is formulated for each design concept, a Cam-Post PS, a Saddle-Ramp, and a Converging Condyle, all with overall anatomic-like surfaces. Each femoral component is then designed, which is then moved through the normal neutral path and laxity paths, which creates the tibial surface. The concepts are evaluated using a Desktop Knee Machine configured to move the knee dynamically through full flexion while applying combinations of compression, shear and torque; kinematic data being captured optically and plotted using custom software. The normal benchmark was obtained from 10 normal knee specimens, which showed the restraint of the medial femoral condyle to anterior displacement and the overall rollback and laxity laterally. Compared with standard CR and PS designs, the Guided Motion designs were seen to more closely resemble normal. It is proposed that this approach can result in designs which will more likely reproduce a ‘forgotten knee’ and achieve the optimal function for a given patient.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 236 - 236
1 Dec 2013
Bell C Walker P Kummer F Meere P
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Balancing in total knee replacement is generally carried out using the feel and experience of the surgeon, using spacer blocks or distractors. However, such a method is not generally applicable to all surgeons and nor does it provide quantitative data of the balancing itself. One approach is the use of instrumented distractors, which have been used to monitor soft tissue releases or indicate a flexion cut for equal lateral and medial forces. More recently an instrumented tibial trial has been introduced which measures and displays the magnitude and location of the loads on the lateral and medial plateaus, during various manoeuvres carried out at surgery. The data set is then used by the surgeon to determine options, whether soft tissue releases or bone cut adjustments, to achieve lateral-medial equality.

The testing method consisted of mounting the femoral component rigidly in a fixture on the vertical arm of an MTS machine. The tibial component was fixed on to a platform which allowed varus-valgus correction, and where the component could be displaced or rotated in a horizontal plane. Two of each size times 4 sizes of production components were tested. Compressive forces from 0–400N in steps of 50N were applied and the readings taken. There were strong correlations between applied and measured forces with mean Pearson's Correlation Coefficient of 0.958.

The special tests under different conditions did not have any effect on the output values. The output data proved to be repeatable under Central Loading with a maximum standard deviation of ± 15.36N at the highest applied force of 400N. “Low battery” did not adversely affect the data. Applying the load steadily to maximum versus load-unload-zero tests produced similar results. Lubrication versus no lubrication tests produced no changes to the results. There was no cross talk of the electronics within the device when loaded on one condyle. For both central and anterior-posterior loading, the contact points were centered medial-lateral on the GUI display, and tracked contact point translation appropriately.

Anterior-posterior loading did create output load variance at the extremes. However, it enabled the validation of the relationship of the femur on the trial surface. In addition, malrotation would be indicated by the femur riding up on the anterior or posterior tibial edges, important for soft tissue tension in all flexion angles.

In conclusion, the sensors provided data which was accurate to well within a practical range for surgical conditions. In our separate experiments on 10 cadaveric leg specimens, even the same test under controlled conditions could produce variations of up to ± 30N. Hence the sensor outputs indicated whether or not the knee was balanced to that level of tolerance, while the contact point data would indicate contacts too close to the anterior or posterior of the tibial surface.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 193 - 193
1 Dec 2013
Walker P Meere P Bell C
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The purpose of balancing in total knee surgery is to achieve smooth tracking of the knee over a full range of flexion without excessive looseness or tightness on either the lateral or medial sides. Balancing is controlled by the alignment of the bone cuts, the soft tissue envelope, and the constraint of the total knee. Recently, Instrumented Tibial Trials (OrthoSensor) which measure and display the location and magnitude of the forces on the lateral and medial condyles, have been introduced, offering the possibly of predictive and quantitative balancing. This paper presents the results of experiments on 10 lower limb specimens, where the effects of altering the bone cuts or the femoral component size were measured.

A special leg mounting rig was fixed to a standard operating table. A boot was strapped to the foot, and the boot tracked along a horizontal rail to allow flexion-extension. The initial bone cuts were carried out by measured resection using a navigation system. The trial femoral component and the instrumented tibial trial were inserted, and the following tests carried out:

Sag Test; foot lifted up, the trial thickness chosen to produce zero flexion.

Heel Push Test; heel moved towards body to maximum flexion.

Varus-Valgus Test, AP and IXR Tests were also carried out, but not discussed here.

For an initial state of the knee, close to balanced, the lateral and medial contact forces were recorded for the full flexion range. The mean value of the contact forces per condyle was 77.4N, the mean in early flexion (0–60 deg) was 94.2N, and the mean in late flexion (60–120 deg) was 55.7N. The difference was due to the effect of the weight of the leg. One of the following Surgical Variables was then implemented, and the contact forces again recorded.

Distal femoral cut; 2 mm resection (2 mm increase in insert thickness to preserve extension)

Tibial frontal varus, 2 mm lateral stuffing

Tibial frontal valgus, 2 mm medial stuffing

Tibial slope angle increase (5 deg baseline); +2 degrees

Tibial slope angle decrease (5 deg baseline); −2 degrees

Increase in AP size of femoral component (3 mm)

The differences between the condyle force readings before and after the Surgical Variable were calculated for low and high angular ranges. The mean values for the 10 knees of the differences of the above Surgical Variables from the initial balanced state are shown in the chart.

From literature data, the mean tension increase in one collateral ligament is close to 25N/mm up to the toe of the load-elongation graph, and 50N/mm after the toe. Hence in the initial balanced state, the collateral ligaments were elongated by 2–4 mm producing pretension. From the Surgical Variables data, up to 2 mm/2 deg change in bone cuts (or 3 mm femcom change), and collateral ligament releases up to 2 mm, would correct from any unbalanced state to a balanced state.

This data provides useful guidelines for the use of the Instrumented Tibial Trials at surgery, in terms of bone cut adjustments and ligament releases.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 421 - 421
1 Dec 2013
Meere P Walker P Bell C
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Obtaining accurate bone cuts based on mechanical axes and ligament balancing, are necessary for a successful total knee procedure. The OrthoSensor Tibial Trial displays on a GUI the magnitude and location of the lateral and medial contact forces at surgery. The goal of this study was to develop algorithms to inform the surgeon which bone cuts or soft tissue releases were necessary to achieve balancing, from an initial unbalanced state.

A rig was designed for lower body specimens mounted on a standard operating table. SURGICAL TESTS were then defined: Sag Test, leg supported at the foot; Dynamic Heel Push test, flexing to 120 degrees with the foot sliding along a rail; Varus-Valgus test; AP Drawer test; Internal-External Rotation test. The bone cuts were made using a Navigation system, matching the Triathlon PCL retaining knee. To determine the initial thickness of the tibial trial, the Sag Test was performed to reach 0 deg flexion. The Heel Push Test was then performed to check the AP position of the lateral and medial contacts, from which the rotational position of the tibial tray was determined. Pins were used to reproduce this position during the experiments.

SURGICAL VARIABLES were then defined, which would influence the balancing: LCL Stiffness, MCL Stiffness, Distal Femoral Cut Level, Tibial Sagittal Slope, Tibial Varus or Valgus, and AP Femoral Component Length. Balancing was defined as equal lateral and medial forces due to soft tissue tensions throughout the flexion range, equal varus and valgus stiffnesses, and no contacts closer than 10 mm to component edges. All of the above tests were then performed sequentially, and the changes in the contact force readings were considered as a signature of that Surgical Variable.

Testing was carried out on 10 full leg specimens. The Sag Test was the basic test for determining the thickness of the tibial insert. The Heel Push Test was then implemented from which force data throughout flexion was determined; followed by the Varus-Valgus Test. In a surgical case, this data will be used in a decision tree to identify which Surgical Variable required correction. In the experiments, by obtaining the above data for each SURGICAL VARIABLE in turn, we were able to determine a SIGNATURE for each SURGICAL VARIABLE. It was found that there was considerable variation in the force magnitudes between knees. However the SIGNATURES were sufficient to point to the specific SURGICAL VARIABLE requiring correction. In some knees, although there was a dominant SURGICAL VARIABLE, even after correcting for that, there was still an imbalanced state, requiring a second correction.

This research provided the fundamental principles and data for:

Defining tests to be carried out at surgery, to obtain force data to determine the SURGICAL VARIABLE to correct.

Defining the algorithm based on Closest Approach, for building up a database of data for predictive purposes.

How to use the Sag Test and the Varus-Valgus test as primary indicators.

How to use the AP Drawer test and the Internal-External Rotation test as fine tune indicators.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 304 - 304
1 Dec 2013
Arno S Fetto J Bell C Papadopoulos K Walker P
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INTRODUCTION:

The purpose of this study was to determine if a short femoral stem (Lima Corporate, Udine, Italy) would result in a strain distribution which mimicked the intact bone better than a traditional length stem, thereby eliminating the potential for stress-shielding.

METHODS:

A 2 mm thick moldable plastic (PL-1, Vishay Micromeasurements, Raleigh, NC) was contoured to six fourth-generation composite femoral bones (Pacific Research Laboratories, Vashon, WA). The intact femurs were then loaded (82 kg) in a rig which simulated mid-stance single limb support phase of gait (Figure 1). During testing, the femurs were viewed and video recorded through a model 031 reflection polariscope. Observing the photoelastic coating through the polariscope, a series of fringes could be seen, which represented the difference in principal strain along the femur. The fringes were quantified using Fringe Order, N, as per the manufacturers technical notes. In order to analyze the strain distribution, the femur was separated into 6 zones, 3 lateral and 3 medial, and the maximum fringe order determined. Upon completion of testing of the intact femur, the short length femoral stem was inserted and tested, and finally the traditional length femoral stem was inserted and tested. Anterior and lateral radiographs were obtained of the femur with each femoral stem in order to confirm proper alignment.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 2 - 2
1 Aug 2013
Walker P Meere P Bell C
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Obtaining accurate bone cuts based on mechanical axes and ligament balancing, are necessary for a successful total knee procedure. The Orthosensor Tibial Trial displays on a GUI the magnitude and location of the lateral and medial contact forces at surgery. The goal of this study was to develop the algorithms to inform the surgeon which bone cuts or soft tissue releases were necessary to achieve balancing, from an initial unbalanced state.

A rig was designed for lower body specimens mounted on a standard operating table. Surgical Tests were then defined: Sag Test, leg supported at the foot; Dynamic Heel Push test, flexing to 120 degrees with the foot sliding along a rail; Varus-Valgus test; AP Drawer test; Internal-External Rotation test. The bone cuts were made using a Navigation system, to match the Triathlon PCL retaining knee. To determine the initial thickness of the tibial trial, the Sag Test was performed to reach 0 deg flexion. The Heel Push Test was then performed to check the AP position of the lateral and medial contacts, from which the rotational position of the tibial tray was determined. Pins were used to reproduce this position during the experiments.

Surgical Variables were then defined, which would influence the balancing: LCL Stiffness, MCL Stiffness, Distal Femoral Cut Level, Tibial Sagittal Slope, Tibial Varus or Valgus, and AP Femoral Component Length. Balancing was defined as equal lateral and medial forces due to soft tissue tensions throughout the flexion range, equal varus and valgus stiffnesses, and no contacts closer than 10mm to component edges. All of the above tests were then performed sequentially, and the changes in the contact force readings were considered as a signature of that Surgical Variable.

In an actual surgical case, having obtained readings from the Surgical Tests, the data will be compared with the signatures of the Surgical Variables. This will then identify the Variable which needed correction. The Surgical Tests will be repeated and the readings should be closer to balanced. Further correction of another Variable is carried out if necessary. In early clinical cases, it was found that this method allowed for identification of how to reach a balanced state, and achieved soft tissue balancing in a quantitative way.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 197 - 197
1 Mar 2010
McEwen P Harris A Bell C
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A technical goal in total knee arthroplasty is the production of a neutral coronal plane mechanical axis. Errors may produce large mechanical axis deviations precipitating early implant failure. This study sought to test if measured distal femoral resection produced more accurate and consistent coronal alignment than arbitrarily set distal femoral resection.

Data from a cohort of 255 consecutive unselected primary total knee arthroplasties undertaken by the senior author (PM) was collected prospectively and independently assessed. In the first 167 cases distal femoral resection was arbitrarily set to 5 degrees of valgus. In the remaining 88 cases the distal femoral resection angle was determined on a preoperative long leg standing AP radiograph. Postoperative coronal alignment was measured on long leg standing AP radiograph in all cases.

The measured distal femoral valgus angle was between 4 and 7 degrees. An equal number measured either 5 or 6 degrees and accounted for 85% of the total number. Statistically insignificant improvements in mean axis and standard deviation were observed in the measured group: mean axis deviation −0.31 vs −0.51: p=0.17 (independent samples t test) and standard deviation 0.91 vs 1.09: p=0.055 (Levene test).

Acceptable coronal alignment in total knee arthroplasty can reliably be obtained with conventional instrumentation. Improvement in standard deviation with measured distal femoral valgus angle approaches statistical significance.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 395 - 395
1 Oct 2006
Jennings L Bell C Ingham E Komistek R Stone M Fisher J
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Introduction: In vivo fluoroscopic studies have shown considerable differences in kinematics between different designs of knee prostheses and compared to the natural knee. Most noticeably, lift off of the femoral condyles from the tibial insert has been observed in many patients (Dennis et al, 2003). The aim of this study was to simulate lateral femoral condylar lift off in vitro and to compare the wear of fixed bearing knee prostheses with and without lift off.

Materials and Methods: 12 PFC Sigma cruciate retaining fixed bearing knees (DePuy, Leeds, UK) were tested. The 10 mm thick inserts were manufactured from GUR1020 UHMWPE and gamma irradiated in a vacuum. The inserts snap fitted into titanium alloy tibial trays, and articulated against Co-Cr-Mo alloy femoral components. The testing was carried out on six station simulators (Prosim, Manchester, UK). Femoral axis loading (maximum 2.6 kN) and the flex-ion-extension profile (0–58°) were adopted from ISO 14243 (1999). The internal/external rotation was ± 5° and anterior/ posterior displacement 0–5 mm. Six of the knees were tested under these standard conditions for 4 million cycles. A further six knees were tested under these conditions with the addition of lateral femoral condylar lift off, for 5 million cycles. The lift off was achieved by introducing an adduction moment to the tibial carriage, producing a separation of approximately 1 mm during the swing phase of the simulator cycle. The simulator was run at 1 Hz and the lubricant used was 25% newborn calf serum. Wear was determined gravimetrically, using unloaded soak controls to adjust for moisture uptake. Statistical analysis was performed using Students t-test (p < 0.05).

Results: Under the standard kinematic conditions the mean wear rate with 95% confidence limits was 8.8 ± 4.8 mm3/million cycles. When femoral condylar lift off was simulated the mean wear rate increased to 16.2 ± 2.9 mm3/million cycles, which was statistically significantly higher (p < 0.01). The wear patterns on the femoral articulating surface of all the inserts showed more burnishing wear on the medial condyle than the lateral. However, in the simulation of lift off the medial condyle was even more aggressively worn with evidence of adhesion and surface defects.

Discussion: The presence of lateral femoral condylar lift off resulted in a higher wear rate on the medial compartment of the PFC Sigma fixed bearing knee. This could be due to elevated contact stresses as the lateral lift off produced uneven loading of the bearing. Further, additional medial/lateral sliding of the medial condyle whilst it remained in contact may have accelerated the wear by cross shearing of the polyethylene in the medial/lateral direction. This direction is weakened when the polyethylene is preferentially molecularly orientated by sliding in the flexion-extension axis. The implications of condylar lift off include premature wear of the polyethylene and possible component loosening.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 406 - 406
1 Oct 2006
Katta J Bell C Carrick L Ingham E Aggeli A Boden N Waigh T Jin Z Fisher J
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Viscosupplementation is the current treatment modality for early stage arthritis and in some cases for delaying joint replacement procedures. Rheological properties similar to that of synovial fluid and high molecular weight have been recognized as the determining factors in hyaluronic acids (HA) therapeutic and analgesic value (1). In this study, the self assembly of peptides into beta-sheet structures in solution (24) is explored to develop novel biocompatible injectable joint lubricants. These peptides can be delivered into the joint easily in their low viscosity monomer form, while they are designed to self-assemble in situ under physiological conditions. Four different peptides P11-4, P11-8, P11-9, and P11-12 were designed based on the chemical motif of hyaluronic acid and were found to self-assemble into nematic fluids and gels under physiological conditions. Friction characteristics of these peptides as lubricants were evaluated in a bovine cartilage on cartilage model using a simple pin on plate geometry and under various sliding conditions. Friction tests were carried out using both healthy and damaged bovine cartilage samples, to study the therapeutic effect of these peptides as lubricants. Further, a rheometer with cone-on-plate configuration was used to study these peptides in shear viscosity and oscillatory shear modes to determine their viscoelastic properties. Both the friction properties and rheological behaviour of the peptides were compared to that of a commercially available hyaluronic acid preparation that was tested along with the peptides. Peptide P11-9 was found to have very similar viscoelastic properties to that of HA, and was also the most effective in friction level reduction among the four peptides tested. When compared to HA, P11-9 showed slightly better friction characteristics in all the healthy cartilage models, while HA was the best lubricant in damaged cartilage models when compared to P11-9 and other peptides. The results indicate that these novel self assembling peptides can be developed as a new generation of synthetic viscosupplements for the treatment of early stage arthritis.