A comparison of patient-specific and conventional instrumentation for total knee arthroplasty: a multicentre randomised controlled trial.

In this study we randomised 140 patients who were due to undergo primary total knee arthroplasty (TKA) to have the procedure performed using either patient-specific cutting guides (PSCG) or conventional instrumentation (CI). The primary outcome measure was the mechanical axis, as measured at three months on a standing long-leg radiograph by the hip-knee-ankle (HKA) angle. This was undertaken by an independent observer who was blinded to the instrumentation. Secondary outcome measures were component positioning, operating time, Knee Society and Oxford knee scores, blood loss and length of hospital stay. A total of 126 patients (67 in the CI group and 59 in the PSCG group) had complete clinical and radiological data. There were 88 females and 52 males with a mean age of 69.3 years (47 to 84) and a mean BMI of 28.6 kg/m(2) (20.2 to 40.8). The mean HKA angle was 178.9° (172.5 to 183.4) in the CI group and 178.2° (172.4 to 183.4) in the PSCG group (p = 0.34). Outliers were identified in 22 of 67 knees (32.8%) in the CI group and 19 of 59 knees (32.2%) in the PSCG group (p = 0.99). There was no significant difference in the clinical results (p = 0.95 and 0.59, respectively). Operating time, blood loss and length of hospital stay were not significantly reduced (p = 0.09, 0.58 and 0.50, respectively) when using PSCG. The use of PSCG in primary TKA did not reduce the proportion of outliers as measured by post-operative coronal alignment.

[1]  D. Zurakowski,et al.  Alignment in total knee arthroplasty. A comparison of computer-assisted surgery with the conventional technique. , 2004, The Journal of bone and joint surgery. British volume.

[2]  B. Hanson,et al.  Navigated total knee replacement. A meta-analysis. , 2007, The Journal of bone and joint surgery. American volume.

[3]  S. Lee,et al.  Is TKA Using Patient-specific Instruments Comparable to Conventional TKA? A Randomized Controlled Study of One System , 2013, Clinical orthopaedics and related research.

[4]  K. Bozic,et al.  The cost-effectiveness of computer-assisted navigation in total knee arthroplasty. , 2007, The Journal of bone and joint surgery. American volume.

[5]  Alex H S Harris,et al.  Component alignment during total knee arthroplasty with use of standard or custom instrumentation: a randomized clinical trial using computed tomography for postoperative alignment measurement. , 2014, The Journal of bone and joint surgery. American volume.

[6]  W. Yau,et al.  Cutting errors in total knee replacement: assessment by computer assisted surgery , 2008, Knee Surgery, Sports Traumatology, Arthroscopy.

[7]  Andrew D Pearle,et al.  Patient specific cutting guides versus an imageless, computer-assisted surgery system in total knee arthroplasty. , 2013, The Knee.

[8]  J. Bellemans,et al.  The Chitranjan Ranawat Award: Is Neutral Mechanical Alignment Normal for All Patients?: The Concept of Constitutional Varus , 2012, Clinical orthopaedics and related research.

[9]  S. Hofmann,et al.  Custom-fit minimally invasive total knee arthroplasty: effect on blood loss and early clinical outcomes , 2013, Knee Surgery, Sports Traumatology, Arthroscopy.

[10]  Daniel J Berry,et al.  Effect of postoperative mechanical axis alignment on the fifteen-year survival of modern, cemented total knee replacements. , 2010, The Journal of bone and joint surgery. American volume.

[11]  F. Mercuriali,et al.  Proposal of an algorithm to help the choice of the best transfusion strategy. , 1996, Current medical research and opinion.

[12]  B. Boonen,et al.  Preliminary experience with the patient-specific templating total knee arthroplasty , 2012, Acta orthopaedica.

[13]  J. Argenson,et al.  No Benefit of Patient-specific Instrumentation in TKA on Functional and Gait Outcomes: A Randomized Clinical Trial , 2014, Clinical orthopaedics and related research.

[14]  Sébastien Lustig,et al.  Unsatisfactory accuracy as determined by computer navigation of VISIONAIRE patient-specific instrumentation for total knee arthroplasty. , 2013, The Journal of arthroplasty.

[15]  Olivier Ethgen,et al.  Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. , 2004, The Journal of bone and joint surgery. American volume.

[16]  B. Boonen,et al.  Intra-operative results and radiological outcome of conventional and patient-specific surgery in total knee arthroplasty: a multicentre, randomised controlled trial , 2013, Knee Surgery, Sports Traumatology, Arthroscopy.

[17]  E. T. Ek,et al.  The long leg radiograph is a reliable method of assessing alignment when compared to computer-assisted navigation and computer tomography. , 2013, The Knee.

[18]  R Richards,et al.  A review of rapid prototyped surgical guides for patient-specific total knee replacement. , 2012, The Journal of bone and joint surgery. British volume.

[19]  L. Dorr,et al.  Rationale of the Knee Society clinical rating system. , 1989, Clinical orthopaedics and related research.

[20]  S. Hofmann,et al.  Patient-specific total knee arthroplasty: the importance of planning by the surgeon , 2013, Knee Surgery, Sports Traumatology, Arthroscopy.

[21]  William J Hozack,et al.  Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. , 2008, The Journal of arthroplasty.

[22]  A. Lombardi,et al.  Improved Accuracy of Alignment With Patient-specific Positioning Guides Compared With Manual Instrumentation in TKA , 2012, Clinical orthopaedics and related research.

[23]  Johan Bellemans,et al.  Patient-specific Guides Do Not Improve Accuracy in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial , 2013, Clinical orthopaedics and related research.

[24]  Carsten Perka,et al.  Small Improvements in Mechanical Axis Alignment Achieved With MRI versus CT-based Patient-specific Instruments in TKA: A Randomized Clinical Trial , 2014, Clinical orthopaedics and related research.

[25]  P. Choong,et al.  Coronal alignment correlates with outcome after total knee arthroplasty: five-year follow-up of a randomized controlled trial. , 2012, The Journal of arthroplasty.

[26]  J. Argenson,et al.  Rotation in total knee arthroplasty: no difference between patient-specific and conventional instrumentation , 2013, Knee Surgery, Sports Traumatology, Arthroscopy.

[27]  T. Cooke,et al.  Frontal plane knee alignment: a call for standardized measurement. , 2007, The Journal of rheumatology.

[28]  W. Hamilton,et al.  Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial. , 2013, The Journal of arthroplasty.

[29]  P. Boisrenoult,et al.  Pin track induced fractures around computer-assisted TKA. , 2010, Orthopaedics & traumatology, surgery & research : OTSR.

[30]  M. Ritter,et al.  Tibial Component Failure Mechanisms in Total Knee Arthroplasty , 2004, Clinical orthopaedics and related research.

[31]  C. Pornrattanamaneewong,et al.  A prospective randomised controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. , 2013, The bone & joint journal.

[32]  A. Carr,et al.  Questionnaire on the perceptions of patients about total hip replacement. , 1996, The Journal of bone and joint surgery. British volume.

[33]  M. Ritter,et al.  The effect of alignment and BMI on failure of total knee replacement. , 2011, The Journal of bone and joint surgery. American volume.

[34]  Robert L. Barrack,et al.  Are Patient-specific Cutting Blocks Cost-effective for Total Knee Arthroplasty? , 2012, Clinical orthopaedics and related research.

[35]  Liesbeth Bruckers,et al.  Functional and radiographic short-term outcome evaluation of the Visionaire system, a patient-matched instrumentation system for total knee arthroplasty. , 2013, The Journal of arthroplasty.

[36]  Ning Liu,et al.  The value of patient-matched instrumentation in total knee arthroplasty. , 2012, The Journal of arthroplasty.

[37]  Andrea Ferretti,et al.  Evaluation of the accuracy of a patient-specific instrumentation by navigation , 2013, Knee Surgery, Sports Traumatology, Arthroscopy.

[38]  Christopher L. Peters,et al.  Patient-specific Total Knee Arthroplasty Required Frequent Surgeon-directed Changes , 2013, Clinical orthopaedics and related research.

[39]  R. Barrack,et al.  Patient specific cutting blocks are currently of no proven value. , 2012, The Journal of bone and joint surgery. British volume.

[40]  Georg Matziolis,et al.  A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. , 2007, The Journal of bone and joint surgery. American volume.

[41]  R. Barrack,et al.  Do Patient-specific Guides Improve Coronal Alignment in Total Knee Arthroplasty? , 2012, Clinical orthopaedics and related research.