A randomized controlled trial investigating the value of patient-specific instrumentation for total knee arthroplasty in the Canadian healthcare system.

AIMS The purpose of the present study was to compare patient-specific instrumentation (PSI) and conventional surgical instrumentation (CSI) for total knee arthroplasty (TKA) in terms of early implant migration, alignment, surgical resources, patient outcomes, and costs. PATIENTS AND METHODS The study was a prospective, randomized controlled trial of 50 patients undergoing TKA. There were 25 patients in each of the PSI and CSI groups. There were 12 male patients in the PSI group and seven male patients in the CSI group. The patients had a mean age of 69.0 years (sd 8.4) in the PSI group and 69.4 years (sd 8.4) in the CSI group. All patients received the same TKA implant. Intraoperative surgical resources and any surgical waste generated were recorded. Patients underwent radiostereometric analysis (RSA) studies to measure femoral and tibial component migration over two years. Outcome measures were recorded pre- and postoperatively. Overall costs were calculated for each group. RESULTS There were no differences (p > 0.05) in any measurement of migration at two years for either the tibial or femoral components. Movement between one and two years was < 0.2 mm, indicating stable fixation. There were no differences in coronal or sagittal alignment between the two groups. The PSI group took a mean 6.1 minutes longer (p = 0.04) and used a mean 3.4 less trays (p < 0.0001). Total waste generated was similar (10 kg) between the two groups. The PSI group cost a mean CAD$1787 more per case (p < 0.01). CONCLUSION RSA criteria suggest that both groups will have revision rates of approximately 3% at five years. The advantages of PSI were minimal or absent for surgical resources used and waste eliminated, and for meeting target alignment, yet had significantly greater costs. Therefore, we conclude that PSI may not offer any advantage over CSI for routine primary TKA cases. Cite this article: Bone Joint J 2019;101-B:565-572.

[1]  S. Young,et al.  Outcome of kinematic alignment using patient-specific instrumentation versus mechanical alignment in TKA: a meta-analysis and subgroup analysis of randomised trials , 2018, Archives of Orthopaedic and Trauma Surgery.

[2]  J. V. van Leeuwen,et al.  A 2-year RSA study of the Vanguard CR total knee system: A randomized controlled trial comparing patient-specific positioning guides with conventional technique , 2018, Acta orthopaedica.

[3]  M. Schotanus,et al.  Favourable alignment outcomes with MRI-based patient-specific instruments in total knee arthroplasty , 2018, Knee Surgery, Sports Traumatology, Arthroscopy.

[4]  D. Holdsworth,et al.  Varus tibial alignment is associated with greater tibial baseplate migration at 10 years following total knee arthroplasty , 2018, Knee Surgery, Sports Traumatology, Arthroscopy.

[5]  Wei Huang,et al.  CT- versus MRI-based patient-specific instrumentation for total knee arthroplasty: A systematic review and meta-analysis. , 2017, The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland.

[6]  I. Alcelik,et al.  A comparison of short term radiological alignment outcomes of the patient specific and standard instrumentation for primary total knee arthroplasty: A systematic review and meta-analysis , 2017, Acta orthopaedica et traumatologica turcica.

[7]  Peter Fennema,et al.  Efficacy of Patient-Specific Instruments in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis , 2017, The Journal of bone and joint surgery. American volume.

[8]  K. Phan,et al.  Accuracy of MRI-based vs. CT-based patient-specific instrumentation in total knee arthroplasty: A meta-analysis. , 2017, Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association.

[9]  F. Hossain,et al.  A Meta-analysis of Functional Outcomes in Patient-Specific Instrumented Knee Arthroplasty , 2016, The Journal of Knee Surgery.

[10]  Sujit Kumar Tripathy,et al.  Does Patient-Specific Instrumentations Improve Short-Term Functional Outcomes After Total Knee Arthroplasty? A Systematic Review and Meta-Analysis. , 2016, The Journal of arthroplasty.

[11]  D. Fick,et al.  Patient-specific instrumentation does not improve radiographic alignment or clinical outcomes after total knee arthroplasty , 2016, Acta orthopaedica.

[12]  M. Teeter,et al.  Migration of a cemented fixed-bearing, polished titanium tibial baseplate (Genesis II) at ten years : a radiostereometric analysis. , 2016, The Bone & Joint Journal.

[13]  T. Smith,et al.  Favourable rotational alignment outcomes in PSI knee arthroplasty: A Level 1 systematic review and meta-analysis. , 2016, The Knee.

[14]  Denis Nam,et al.  The Mark Coventry Award: Custom Cutting Guides Do Not Improve Total Knee Arthroplasty Clinical Outcomes at 2 Years Followup , 2016, Clinical orthopaedics and related research.

[15]  A. Ranawat,et al.  Patient-Specific Total Knees Demonstrate a Higher Manipulation Rate Compared to "Off-the-Shelf Implants". , 2013, The Journal of arthroplasty.

[16]  G-C Lee.  Patient-specific cutting blocks: Of Unproven Value. , 2016, The bone & joint journal.

[17]  Emmanuel Thienpont,et al.  The indirect cost of Patient-Specific Instruments. , 2015, Acta orthopaedica Belgica.

[18]  K. Chiu,et al.  Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial , 2015, Knee Surgery, Sports Traumatology, Arthroscopy.

[19]  N. Stall,et al.  Surgical waste audit of 5 total knee arthroplasties. , 2013, Canadian journal of surgery. Journal canadien de chirurgie.

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

[21]  J. Plevier,et al.  Early migration of tibial components is associated with late revision , 2012, Acta orthopaedica.

[22]  Johan Kärrholm,et al.  Radiostereometric analysis of early implant migration – a valuable tool to ensure proper introduction of new implants , 2012, Acta orthopaedica.

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

[24]  A. Lombardi,et al.  Customization of cutting blocks: Can this address the problem? , 2012, Current Reviews in Musculoskeletal Medicine.

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

[26]  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.

[27]  J. Kärrholm,et al.  RSA and registries: the quest for phased introduction of new implants. , 2011, The Journal of bone and joint surgery. American volume.

[28]  Henrik Malchau,et al.  The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. , 2011, The Journal of arthroplasty.

[29]  Gunnar Flivik,et al.  Guidelines for standardization of radiostereometry (RSA) of implants , 2005, Acta orthopaedica.

[30]  S. Toksvig-Larsen,et al.  Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. , 1995, The Journal of bone and joint surgery. British volume.

[31]  J. Kärrholm,et al.  Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. , 1994, The Journal of bone and joint surgery. British volume.