Computer Aided Surgery F o r P NON-INVASIVE COMPUTER-ASSISTED MEASUREMENT OF e KNEE ALIGNMENT e r Journal: Computer Aided Surgery R Manuscript ID: TCAS-2011-0014 Manuscript Type: Original Paper e Date Submitted by the v 11-Mar-2011 Author: i Complete List of Authors: Clarke, Jon; Golden Jubielee National Hospital, Orthopaedics; University of Strathclyde, Department of Bioengineering Riches, Philip; University of Strathclyde, Department of Bioengineering w Picard, Frederic; Golden Jubilee N ational Hospital, Orthopaedics Deakin, Angela; Golden Jubilee National Hospital, Orthopaedics Keywords: knee alignment, infrared tracking, nOon-invasive, computer-assisted n l y URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Page 1 of 32 Computer Aided Surgery 1 2 3 Title page 4 5 6 7 NON-INVASIVE COMPUTER-ASSISTED MEASUREMENT OF KNEE 8 ALIGNMENT 9 10 11 12 Jon V. Clarke (MRCS)a,b, Philip E. Riches (PhD)a, Frederic Picard (MD)b, Angela H. 13 14 Deakin (PhD)a,b F 15 16 o 17 a Department of Bioengineering, University of Strathclyde, Glasgow, Scotland 18 r 19 b Department of Ort hopaedics, Golden Jubilee National Hospital, Clydebank, Scotland 20 21 P 22 23 Running title: Non-invasieve measurement of knee alignment 24 e 25 26 r Corresponding Author: 27 28 Mr Jon Clarke 29 R 30 Clinical Research Fellow 31 e Department of Orthopaedics 32 v 33 Golden Jubilee National Hospital i 34 35 Agamemnon Street e 36 37 Clydebank 38 w 39 East Dunbartonshire 40 G81 4DY 41 O 42 Tel: +44 (0)141 951 5966 43 n 44 Fax: +44 (0)141 951 5081 l 45 46 Email: [email protected] y 47 48 49 50 51 52 53 54 55 56 57 58 59 60 1 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Computer Aided Surgery Page 2 of 32 1 2 3 Abstract 4 5 The quantification of knee alignment is a routine part of orthopaedic practice and is 6 7 8 important for monitoring disease progression, planning interventional strategies and 9 10 follow-up of patients. Currently available technologies such as radiographic 11 12 13 measurements have a number of drawbacks. The aim of this study was to validate a 14 F 15 potentially improved technique of measuring knee alignment under different conditions. 16 o 17 An image-free navigation system was adapted for non-invasive use through the 18 r 19 20 development of external infra-red tracker mountings. Stability was assessed by 21 P 22 comparing the variance (F Test) of repeated mechanical femoro-tibial (MFT) angle 23 e 24 measurements for a volunteeer and a leg model. MFT angles were then measured supine, 25 26 r 27 standing and with varus-valgus stress for asymptomatic volunteers who each had two 28 29 R separate registrations and repeated measurements for each condition. The mean 30 31 e difference and 95% limits of agreement were used to assess intra-registration and inter- 32 v 33 i 34 registration repeatability. For multiple registrations the range of measurements for the 35 e 36 external mountings was 1° larger than the rigid model with statistically similar variance 37 38 w 39 (p=0.34). Thirty volunteers were assessed (19 males, 11 f emales) with mean age 41 years 40 41 (20-65) and mean BMI 26 (19-34). For intra-registratiOon repeatability, consecutive 42 43 n coronal alignment readings agreed to almost ±1° with up to ±0.5° loss of repeatability for 44 l 45 46 coronal alignment measured before and after stress manoeuvres andy a ±0.2° following 47 48 stance. Sagittal alignment measurements were less repeatable overall by an approximate 49 50 factor of two 51 52 53 Inter-registration agreement limits for coronal and sagittal supine MFT angles were ±1.6° 54 55 and ±2.3° respectively. Varus and valgus stress measurements agreed to within ±1.3° and 56 57 58 59 60 2 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Page 3 of 32 Computer Aided Surgery 1 2 3 ±1.1° respectively. Agreement limits for standing MFT angles were ±2.9° (coronal) and 4 5 ±5.0° (sagittal) which may have reflected a variation in stance between measurements. 6 7 8 The system provided repeatable, real-time measurements of coronal and sagittal knee 9 10 alignment under a number of dynamic, real-time conditions offering a potential 11 12 13 alternative to radiographs. 14 F 15 16 o 17 Key words: knee alignment, non-invasive, infrared tracking, computer-assisted 18 r 19 20 21 P 22 23 e 24 e 25 26 r 27 28 29 R 30 31 e 32 v 33 i 34 35 e 36 37 38 w 39 40 41 O 42 43 n 44 l 45 46 y 47 48 49 50 51 52 53 54 55 56 57 58 59 60 3 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Computer Aided Surgery Page 4 of 32 1 2 3 Introduction 4 5 Knee joint alignment is an important parameter that has been extensively investigated in 6 7 8 the context of osteoarthritis (OA). Radiographic and magnetic resonance imaging (MRI) 9 10 studies have provided evidence that coronal malalignment is associated with an increased 11 12 13 incidence [1] of tibiofemoral OA and risk of progression [2-5]. The importance of 14 F 15 coronal alignment in reconstructive surgery of the knee has been widely accepted with 16 o 17 the recognition that malpositioning can lead to early prosthesis loosening [6], with 18 r 19 20 reported failure rates of 67% for varus knee prostheses versus 29% for knee prostheses in 21 P 22 a neutral position [7], together with increased polyethylene wear and poor overall 23 e 24 function [8,9]. Accurate meeasurement of knee alignment is therefore important for the 25 26 r 27 monitoring of patients with OA, the subsequent planning of surgical interventions and the 28 29 R assessment of treatment outcomes. 30 31 e 32 v 33 i 34 The standard measurement of knee alignment often relies on clinical evaluation in 35 e 36 conjunction with radiographs that centre on the knee joint. However, human assessment 37 38 w 39 of angles is known to be poor [10] and the accuracy of a lignment estimates under these 40 41 circumstances may be no better than the order of ±5° [11]O. The use of knee radiographs 42 43 n has been found to be an inaccurate measure of mechanical lower limb alignment [12] and 44 l 45 46 so its role in assessing knee alignment for planning intervention straytegies and for post- 47 48 operative evaluation may be limited. Full-length hip-knee-ankle radiographs have 49 50 therefore been increasingly adopted to provide more reliable pre- and post-operative 51 52 53 information and are widely considered the gold standard for measuring knee alignment. 54 55 In spite of enabling measurement of the mechanical femoro-tibial (MFT) angle these 56 57 58 59 60 4 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Page 5 of 32 Computer Aided Surgery 1 2 3 radiographs are susceptible to limb positioning errors with apparent variations in 4 5 alignment produced as a result of knee flexion or rotation [13,14]. Computed tomography 6 7 8 (CT) imaging can overcome these positional artefacts by providing a 3D evaluation of 9 10 lower limb anatomy but is unable to provide weight-bearing information as subjects are 11 12 13 required to be supine. Further drawbacks of both imaging modalities include limited 14 F 15 availability, exposure of the pelvis to ionising radiation and the lack of more normal 16 o 17 physiological control data from populations not typically exposed to them such as 18 r 19 20 children and non-arthritic subjects with knee ligament injuries. 21 P 22 23 e 24 Due to the limitations of radeiographs and CT scans, several alternative clinical measures 25 26 r 27 of alignment have been reported and include techniques ranging from direct visual 28 29 R estimation to measurement adjuncts such as callipers, manual goniometers and plumb- 30 31 e line methods [15,16]. These methods are inexpensive, avoid radiation exposure and are 32 v 33 i 34 relatively quick to perform with instant measurement results. However the reported errors 35 e 36 are potentially too large for use in planning and follow-up of surgical interventions such 37 38 w 39 as replacement arthroplasty and corrective osteotomy whe re higher levels of accuracy are 40 41 often required [16]. O 42 43 n 44 l 45 46 Out with the clinic situation a number of new technologies using infyrared tracking have 47 48 been introduced intra-operatively to provide surgeons with quantitative measurement 49 50 tools that permit real time assessment of lower limb kinematics [17-19]. These systems 51 52 53 have high levels of precision and can achieve angular and tibiofemoral gap measurements 54 55 of within 1° or 1mm respectively [20,21]. At present these quantitative measurement 56 57 58 59 60 5 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Computer Aided Surgery Page 6 of 32 1 2 3 techniques have restricted scope due to their reliance on the rigid bony fixation of 4 5 trackers. Adapting this technology for non-invasive patient assessment is challenging due 6 7 8 to the soft tissue artefacts associated with the external mounting of trackers. Previous 9 10 investigations to quantify the relative movement of external marker sets relative to 11 12 13 underlying bones have reported large potential errors and questioned the value of these 14 15 methods Ffor accurate kinematic analysis [22,23]. However these functional methods of 16 o 17 determining rotational joint centres and resultant mechanical lower limb alignment are 18 r 19 20 often in the context of gait analysis or involve active joint movement with contraction of 21 P 22 the underlying muscles. A more recent study sought to minimise [24] these potential 23 e 24 artefacts by measuring statiec standing lower limb alignment with position capture and 25 26 r 27 skin markers along with external anatomical landmarks. The reliance on anthropometric 28 29 R measurements to predict joint centre location may have accounted for only a moderate 30 31 e correlation with corresponding long-leg radiographs in an experimental set-up not readily 32 v 33 i 34 adaptable to an out-patient clinic. 35 e 36 37 38 w 39 Given the subjective nature of clinical examination a nd the limitations of different 40 41 measurement techniques reported to date, there is potential Oto improve current methods of 42 43 n assessing knee joint alignment. This paper reports the validation of a non-invasive system 44 l 45 46 for measuring lower limb alignment based on a commercially availabyle infrared tracking 47 48 technology with kinematic registration. Our hypothesis was that repeatable, real-time 49 50 measurements of mechanical knee alignment under a number of conditions could be 51 52 53 obtained in a clinic situation. 54 55 56 57 58 59 60 6 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Page 7 of 32 Computer Aided Surgery 1 2 3 Materials and Methods 4 5 Infra-red tracking system 6 7 8 An image-free navigation system (Orthopilot®, BBraun Aesculap, Tuttlingen, Germany), 9 10 that consisted of an optical localiser, active infrared (IR) trackers, a pre-calibrated probe 11 12 13 to digitise anatomical landmarks and a foot pedal that enabled ‘hands-free’ data recording 14 F 15 was chosen due to its current clinical use. High tibial osteotomy (HTO) software 16 o 17 (Orthopilot® HTO version 1.5, BBraun Aesculap, Tuttlingen, Germany) was used for the 18 r 19 20 kinematic determination of hip, knee and ankle centres and resultant generation of 21 P 22 coronal and sagittal MFT angles. Coronal alignment was defined with varus negative and 23 e 24 valgus positive, whilst sagitteal alignment was defined with hyperextension negative and 25 26 r 27 flexion positive. 28 29 R 30 31 e Rigid tracker mounting model 32 v 33 i 34 A metal lower limb model was designed and manufactured to provide optimum 35 e 36 conditions for measuring knee alignment. This consisted of metal rods representing a 37 38 w 39 femur, tibia and a foot with rigidly attached tracker moun ts and mechanical hip, knee and 40 41 ankle joints with the required range of movement for rOegistration of their rotational 42 43 n centres (Figure 1). 44 l 45 46 y 47 48 Non-invasive tracker mounting 49 50 Tracker mountings for the thigh, calf and mid-foot regions were developed using metal 51 52 53 base plates and broad straps made from standard strength elastic webbing (542, E&E 54 55 56 57 58 59 60 7 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Computer Aided Surgery Page 8 of 32 1 2 3 Accessories, UK). A variety of lengths were made with a sequence of eyelets at either 4 5 end to connect to the base plate and enable further adjustment of strap size (Figure 2). 6 7 8 9 10 Tracker stability testing 11 12 13 In order to quantify the soft tissue artefacts of the non-invasive mountings, the 14 F 15 repeatability of the measurement of coronal knee alignment for both the leg model and 16 o 17 for the right lower limb of a slim, female volunteer was determined. The volunteer was 18 r 19 20 asked to relax whilst lying supine on an examination couch to ensure that all movements 21 P 22 were passive. The registration process followed that which would be employed intra- 23 e 24 operatively in the normal uese of the software. It began with the identification of the 25 26 r 27 kinematic centre of the hip joint which required a slow, controlled circumduction of the 28 29 R thigh. The manoeuvre was performed in this manner to avoid moving the pelvis and 30 31 e subsequently altering the location of the rotational centre of the femoral head. If there 32 v 33 i 34 was excessive movement of the pelvis or the trackers, then this could have resulted in a 35 e 36 wider, “non-spherical” spread of acquired hip joint centre (HJC) points that was out with 37 38 w 39 the required precision of the system [25]. This would result in rejection of the HJC 40 41 acquisition and the instruction to repeat the circumduction Omanoeuvre until the spread of 42 43 n measured points was within the required threshold. The kinematic ankle centre was 44 l 45 46 determined next by attaching a tracker to the dorsum of the foot anyd then dorsi-flexing 47 48 and plantar-flexing the ankle. The rotational centre of the knee joint was then acquired by 49 50 flexing and extending the knee between 0 and 90° as well as rotating the tibia on the 51 52 53 femur at 90° of flexion. Following a single registration the trackers were left in position 54 55 and 20 consecutive MFT angle recordings were made with the rigid leg model stationary 56 57 58 59 60 8 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected] Page 9 of 32 Computer Aided Surgery 1 2 3 and with the volunteer instructed to remain as still as possible. The full registration 4 5 process was then repeated a further 20 times on 13 different days to quantify additional 6 7 8 soft tissue artefacts associated with removal and re-attachment of the trackers. Statistical 9 10 analysis was performed using SPSS version 17 (SPSS Inc, Chicago, IL, USA) and F tests 11 12 13 used for comparison of the variances of the repeated data sets 14 F 15 16 o 17 Repeatability testing 18 r 19 20 All experimental procedures were approved by the University Ethics Committee and, 21 P 22 after giving informed consent, 30 volunteers were recruited (19 males and 11 females) 23 e 24 with a mean age of 41 yeares (range 20-65) and a mean body mass index (BMI) of 26 25 26 r 27 (range 19-34). Participants confirmed no acute knee symptoms and no history of joint 28 29 R replacement. Basic demographic data were recorded prior to assessment of the right 30 31 e lower limb. Two kinematic registration processes were performed using the appropriate 32 v 33 i 34 passive clinical manoeuvres described above. After each registration, the immediate 35 e 36 coronal and sagittal alignments in full extension were recorded with the lower limb 37 38 w 39 supported at the heel and the subject told to relax. Follo wing this, coronal and sagittal 40 41 alignment was measured with subjects asked to assumeO their normal bipedal stance. 42 43 n Returning the participant to the supine position, the coronal and sagittal alignment 44 l 45 46 measurements were then performed twice and subsequent to this fyive manual stresses 47 48 were applied to the knee joint by a single clinician to determine varus and valgus angular 49 50 displacements. During these stress manaouevres, the knee was held between 0° and 5° of 51 52 53 flexion as indicated by the on-screen measurement of sagittal MFT angle. If the knee 54 55 coud not extend to 0° then the stress measurments were performed within a 5° window of 56 57 58 59 60 9 URL: http:/mc.manuscriptcentral.com/tcas Email: [email protected]
Description: