ARTICLE IN PRESS Journal of Biomechanics 36 (2003) 1391–1395 Short communication A novel method for measuring medial compartment pressures within the knee joint in-vivo Iain A. Andersona,*, Andrew A. MacDiarmidb, M. Lance Harrisc, R. Mark Gilliesc, Rhona Phelpsd, W.R. Walshc a Bioengineering Institute, University of Auckland, Floor 6, 70 Symonds Street, Auckland, New Zealand b Tauranga Hospital, Tauranga, New Zealand c Orthopaedic Research Laboratories, University of New South Wales, Prince of Wales Hospital, Sydney 2031, Australia d Industrial Research Ltd., Auckland, New Zealand Accepted 31 March 2003 Abstract A novel method for the measurement of knee joint forces in-vivo is described. A thin (0.2 mm) flexible electronic pressure sensor was inserted through a narrow arthroscopic portal into the osteoarthritic medial compartment of the knee joint. The sensor partially covered the load bearing area. The surgery was performed under local anaesthetic during normal arthroscopic examination following patient consent. Results are presented for 11 patients. The method was used in a pilot study to assess the effects of four valgus knee braces on medial compartment forces. An analysis of variance could not detect un-loading by any brace although there were large variations in force output. These variations may be attributable to shifts in the sensor position. In-vivo measurement of joint force is technically feasible. r 2003 Elsevier Ltd. All rights reserved. Keywords: Arthroscopy; Pressure sensing; In-vivo measurement; Knee joint; Knee brace; Osteoarthritis 1. Introduction An electronic pressure sensor, implanted during routine arthroscopy, was used for recording intraarticular forces within the medial compartment of the knee. The sensor (Iscan 6900, Tekscan, Boston) consists of a conductive ink grid comprising 121 sensing elements, sandwiched between two layers of polyester film. Other knee contact pressure studies have used Fuji pressure sensitive film (Takahashi et al., 1997; Hayes et al., 1993; Lee et al., 1997; Ihn et al., 1993) in ‘‘open’’ operations under general anaesthetic or cadaveric knees. Fuji Film provides a single recording of the peak pressure distribution. By contrast the Tekscan system can provide a continuous output of pressure distribution, a desirable feature for a transducer to be implanted in-vivo. Werner et al. (1995) suggest that errors in this system could occur due to creep and temperature *Corresponding author. Tel.: +64-9-3737599; fax: +64-9-3677157. E-mail address: i.anderson@auckland.ac.nz (I.A. Anderson). 0021-9290/03/$ - see front matter r 2003 Elsevier Ltd. All rights reserved. doi:10.1016/S0021-9290(03)00158-1 variation but indicates that its thinness (B0.1 mm) and rapid response are valuable resources. The sensor is reliable when used for recording joint pressures during ligament balancing (Wallace et al., 1998) as well as contact area and stress levels in total knee replacements (Harris et al., 1999). To evaluate this technique we have carried out a pilot study to assess the influence of valgus knee braces on medial compartment forces, to test the assertion that braces unload this compartment. Other workers have used imaging technologies to study brace efficacy. Komistek et al. (1999) analysed fluoroscopic images on patients wearing the Bledsoe Thruster brace and measured an average change in condylar separation at heel strike of 1.2 mm on 12 of 15 patients. Horlick and Loomer (1993) could not see a significant change to femoral-tibial angle or joint space on X-ray images of 39 patients with and without the Generation II brace fitted. Matsuno et al. (1997) recorded a change of femoraltibial angle over 12 months from an average of 185.1 to 183.7 (1.4 ) on X-ray images from 12 out of 20 patients ARTICLE IN PRESS 1392 I.A. Anderson et al. / Journal of Biomechanics 36 (2003) 1391–1395 wearing the Generation II brace. Load reduction has been estimated indirectly using instrumented braces in conjunction with gait analysis. Pollo et al. (2001) calculated load reductions for the Generation II brace of up to 17% on the medial side during the stance phase of gait. Self et al. (2000) compared the moment of the body about the knee with the counter-moment generated by the Donjoy Monarch brace to show that this brace can significantly reduce the varus moment at the knee at 20% and 25% of the stance phase. These calculations cannot take into account the additional influences of muscle action and ligamentous restraint. Reliable in-vivo measurement of joint force would overcome this problem and provide an important key to our understanding of brace effectiveness. In the present study our primary goal was to determine whether or not the sensor will continue to work reliably after furling, insertion through an arthroscopic portal and final placement. 2. Methods This study was subject to an independent ethics committee and informed consent was obtained from all patients. Measurements were performed under local anaesthetic on three groups of patients during routine arthroscopic surgery (Group I—patients 1–3, Group II—patients 4–9 and Group III—patients 10–15). Joint forces were measured using a single branch of an Iscan 6900 ‘‘quad’’ electronic pressure sensor of area 196 mm2 (Fig. 1). Cellulose leader tapes to aid in arthroscopic placement were attached to top and bottom faces of each sensor giving a total thickness of 0.2 mm. Sensors were calibrated in compression within a Bionix 858 closed-loop servo-hydraulic mechanical testing system Fig. 1. Tekscan transducer (surface area B2 cm2) held against a femoral condyle. The medial condyle is on the right. (MTS, Minneapolis, MN, USA). Each pressure sensor and its leader tape were sterilised and sealed in a sterile container. During surgery a mid-line viewing port was established in the knee and the free end of the leader tape was inserted through a portal on the medial side. Forceps inserted through a lateral portal gripped the tape. The surgeon pulled the tape through, drawing the sensor into the joint space so that it lay across the middle of the medial tibial plateau (Fig. 2). A probe was used to assist in unfurling the sensor so that it lay flat. The positioning procedure was monitored using an endoscope. Each knee was sealed with a sterile plastic film. For groups II and III the sensor signal response was tested by manually loading and unloading the joint with valgus and varus thrusts to the leg. Patients performed a number of activities including double-leg stance and single-leg stance (Fig. 3). Contact forces in the knee were measured during unassisted stance and with up to 4 different commercial knee braces fitted to the affected knee. The braces used were the Generation II Unloader (Generation II, WA., USA), Donjoy Monarch (Smith and Nephew, Ca., USA), Breg Tradition (Orthobionic Inc., Ca., USA) and the V-Max (Bodyworks, Ca., USA). The braces were adjusted and fitted by a professional orthotist. Ground reaction forces on the affected side were measured using a stand-on load cell (Kistler Instrumente AG, Winterthur, Switzerland, model #9257B). Results are presented for 11 patients; 4 patients were excluded due to technical difficulties with the sensor position (patients 11,13,15) or stand-on load cell data (patient 1). Data was analysed using Tekscan software (Tekscan, South Boston, USA) and Microsoft Excel (Seattle, WA, USA). The total force on the sensor, Fknee was calculated by summing the response from all sensing elements for each Fig. 2. The surgeon pulls the cellulose leader tape (left) out of the lateral portal, thus drawing the Tekscan sensor into the medial portal. ARTICLE IN PRESS I.A. Anderson et al. / Journal of Biomechanics 36 (2003) 1391–1395 1393 each brace-on measurement (Fig. 4). Statistical analyses were performed on Group III using an analysis of variance (ANOVA) with a blocking structure to incorporate the variability due to patient, brace-change, and stance change influences on the sensor signal. The experimental design was unbalanced for the ANOVA. In particular, double-leg stance measurements were taken either once (before single leg stance) or twice (both before and after single leg stance) (refer Fig. 4). To improve the experimental ‘‘balance’’ we used only the first double-leg stance measurements for each no-brace or brace-on measurement set. We also performed a paired comparison t-test (single sided Student’s) on adjacent brace-on and no-brace measurements. The t-test difference was calculated by averaging the two no-brace single or double leg stance measurements that bracketed a brace-on measurement and then subtracting the brace-on measurement. A small value for the probability ‘p’ (o0.01) would support the hypothesis, that significant unloading was taking place. 3. Results Fig. 3. A single leg stance measurement is taken while the patient is wearing a brace. data frame and averaging data frames collected over three 5 s intervals at a sample rate of at least 40 Hz. The non-dimensional relative change in the signal Fstance from single to double leg stance was calculated by dividing the force for single leg stance (Fknee,sls) by the average of adjacent double leg stance measurements (Fknee,dls): Fstance ¼ Fknee;sls =Fknee;dls : The non-dimensional relative load (Frel) was the average value of the force on the knee sensor with the brace on (Fbrace) divided by the average value of the sensor force for the no-brace condition (Fno brace): Frel ¼ Fbrace =Fno brace : Before calculating Frel, both Fbrace and Fno brace were normalised by dividing each by the total force through the leg measured by the Kistler stand-on load cell. Frel was expected to vary from Frel=0 representing complete unloading by the brace to Frel=1 representing no change in loading. For Groups I and II no-brace stance measurements were collected at the beginning of the experimental procedure. For Group III no-brace stance measurements were collected at the start, end and in-between Sensors continued to work after insertion for all patients although signal levels were very low on three patients (patients 11, 13, 15). The relative change in sensor signal output from double to single leg stance (Fstance), calculated for 64 measurements (no-brace and brace-on for 11 patients), was 1.97 (s.d. 1.44). The range for Fstance was 0.65 to 8.91. The relative load for the four braces (Frel) ranged from 0.57–0.88 for single leg stance and from 0.74 to 0.85 for double leg stance. Averaged across the four braces, Frel was 0.78 (s.d. 0.29) and 0.70 (s.d. 0.36) for double and single-leg stance, respectively. For Group III (#10, 12, and 14), the sensor signal during no-brace stance activities displayed a significant degree of variation through the course of an experiment (Figs. 4 and 5). Signals were highest at the start of an experiment (Fig. 4). The ANOVA did not detect a significant unloading by any brace (p=0.389 for the F-ratio of 1.088 on 4 and 20 degrees of freedom) and demonstrated high variation between patients, when changing between braces and changes to stance (single to double). The paired comparison results for double leg stance were p=0.47, n=11 (all braces) and p=0.3, n=2 (best brace). For single leg stance the results were p=0.24, n=11 (all braces) and p=0.06, n=2 (best brace). 4. Discussion Repeated no-brace measurements, on Group III, demonstrated that loading conditions on the sensor were subject to change (Figs. 4 and 5) probably linked to shifts in sensor position, as it settled in, and small ARTICLE IN PRESS 1394 I.A. Anderson et al. / Journal of Biomechanics 36 (2003) 1391–1395 Fig. 4. Tekscan data for patient (a) 10, (b) 12, (c) 14. Knee transducer force levels are presented for the initial valgus (surgeon opens joint) and varus (surgeon closes joint) thrusts (panel 1), no brace double leg (dls) and single leg (sls) stance measurements (panels 2, 4, 6, 8, 10), and brace-on double and single leg stance measurements for each of four separate braces (panels 3, 5, 7, 9). changes to the flexion angle of the knee from measurement to measurement. We could not track sensor position as the sensors could not be seen reliably on X-ray. Sensor position would influence load measurement as the area of the sensor in the joint space was approximately one third or less than the total contact area in the medial compartment of the knee. This estimate is based on measurements of medial knee contact area by Ihn et al. (1993). While it is known how sensor materials covering the full area of contact will influence local contact stresses (Wu et al., 1998), it is not clear how a sensor covering less than the full area of contact will influence these stresses. Thus we limited our study to an analysis of total force on the sensor, not pressure distribution. Tekscan offers larger sensors but the leads on these designs are too wide for fitting through narrow arthroscopic portals. Reducing lead width may aid in future efforts. Osteoarthritic joint surfaces are characterised by regions of healthy cartilage, damaged cartilage and eburnated bone. We postulate that small changes to the angle of knee flexion from measurement to measurement will introduce big changes to contact conditions on the sensor. An additional source of variation would have been due to subjective effects such as muscle activity by the patient but this was not addressed in the current study. The ANOVA on blocked data from Group III and the paired comparison results failed to demonstrate a significant brace effect. This appears to contradict the Frel data which suggested that unloading was of the order of 20–30%. No-brace measurements at the beginning of an experiment were generally high. These measurements were only collected at the start of each experiment for Groups I and II. The ‘‘apparent’’ unloading seen in the Frel data could therefore be the result of settling-in of the sensor material. The results of this study demonstrate that joint forces can be measured in-vivo although a number of issues of ARTICLE IN PRESS I.A. Anderson et al. / Journal of Biomechanics 36 (2003) 1391–1395 1395 Acknowledgements This research was supported by a grant from The New Zealand War Pensions Medical Research Trust Fund. The authors would also like to thank Dr. Murray Smith (Univ. of Auckland) for his help with the statistical analysis and Dr. David Pang (Industrial Research Ltd.) for help with the experimental work. References Fig. 5. No-brace (a) double leg stance and (b) single leg stance results collected on five occasions through the course of the experiment on Group III patients. The signal levels have been normalised relative to the measurements of largest magnitude. The largest magnitude single leg stance measurements occurred at the beginning of the experiment. detail need to be addressed to improve measurement repeatability. These issues would include accurate determination of sensor position, reliable sensor fixation and monitoring of the flexure angle of the knee during measurement. This transducer system can also be used for dynamic force/pressure measurements. For instance, osteoarthritic knee braces provide relief for patients during normal dynamic activities such as walking. 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