A new ligament-compatible patient-specific 3D-printed implant and instrumentation for total ankle arthroplasty: from biomechanical studies to clinical cases

C Faldini, A Mazzotti, C Belvedere, G Durastanti, A Panciera, G Geraci, A Leardini, C Faldini, A Mazzotti, C Belvedere, G Durastanti, A Panciera, G Geraci, A Leardini

Abstract

Background: Computer navigation and patient-specific instrumentation for total ankle arthroplasty have still to demonstrate their theoretical ability to improve implant positioning and functional outcomes. The purpose of this paper is to present a new and complete total ankle arthroplasty customization process for severe posttraumatic ankle joint arthritis, consisting of patient-specific 3D-printed implant and instrumentation, starting from a ligament-compatible design.

Case presentation: The new customization process was proposed in a 57-year-old male patient and involved image analysis, joint modeling, prosthesis design, patient-specific implant and instrumentation development, relevant prototyping, manufacturing, and implantation. Images obtained from a CT scan were processed for a 3D model of the ankle, and the BOX ankle prosthesis (MatOrtho, UK) geometries were customized to best fit the model. Virtual in silico, i.e., at the computer, implantation was performed to optimize positioning of these components. Corresponding patient-specific cutting guides for bone preparation were designed. The obtained models were printed in ABS by additive manufacturing for a final check. Once the planning procedure was approved, the models were sent to final state-of-the-art additive manufacturing (the metal components using cobalt-chromium-molybdenum powders, and the guides using polyamide). The custom-made prosthesis was then implanted using the cutting guides. The design, manufacturing, and implantation procedures were completed successfully and consistently, and final dimensions and location for the implant corresponded with the preoperative plan. Immediate post-op X-rays showed good implant positioning and alignment. After 4 months, clinical scores and functional abilities were excellent. Gait analysis showed satisfactory joint moment at the ankle complex and muscle activation timing within normality.

Conclusions: The complete customization process for total ankle arthroplasty provided accurate and reliable implant positioning, with satisfactory short-term clinical outcomes. However, further studies are needed to confirm the potential benefits of this complete customization process.

Level of evidence: 5.

Keywords: 3D-printing; Custom-made implant; PSI; Surgical treatment; Total ankle arthroplasty; Total ankle replacement.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Anteroposterior and lateral weight-bearing X-rays of patient showing severe ankle arthritis
Fig. 2
Fig. 2
Coronal and sagittal CT sections
Fig. 3
Fig. 3
Typical flow for custom TAA design and manufacturing. a Typical patient during CT scan; in this case, a modern cone beam computed tomography (CBCT) device was used, with patient in weight-bearing. b Screenshots of medical imaging soon after scan of foot and ankle (top) and during segmentation (bottom). c Arthritic ankle with relevant bone models after completion of 3D reconstruction. d Screenshots during virtual planning and custom design: tailoring dimensions and positioning of components as well as model after final virtual implantation and corresponding bone preparation. e Final model of replaced ankle once 3D printed with cheap polymer powders for final check. f Final metal prosthesis components manufactured in Cr-Co-Mo powders just before implantation—after polishing and coating. These shall be implanted back into the original patient
Fig. 4
Fig. 4
Snapshots from virtual preoperative planning after component dimensioning and positioning, and corresponding bone removal: leg in frontal (left) and lateral (right) views, and 3D view of close-up of replaced joint
Fig. 5
Fig. 5
Positioning of first cutting guide designed and manufactured to match exactly the front of the articulation, including the osteophytes
Fig. 6
Fig. 6
Talar and tibial resections performed using oscillating bone saw into the first cutting guide (stabilized with three Kirschner wires)
Fig. 7
Fig. 7
Dedicated spacer confirming proper overall amount of bone resection
Fig. 8
Fig. 8
Positioning of second talar cutting guide stabilized with two Kirschner wires. Talar bone preparation for posterior chamfer and two holes for pegs completed using oscillating bone saw and drill, respectively
Fig. 9
Fig. 9
Final patient-specific 3D-printed implant in place
Fig. 10
Fig. 10
Postoperative anteroposterior and lateral X-rays

References

    1. Brown TD, Johnston RC, Saltzman CL, Marsh JL, Buckwalter JA. Posttraumatic osteoarthritis: a first estimate of incidence, prevalence, and burden of disease. J Orthop Trauma. 2006;20(10):739–744. doi: 10.1097/01.bot.0000246468.80635.ef.
    1. Nwankwo EC, Jr, Labaran LA, Athas V, Olson S, Adams SB. Pathogenesis of posttraumatic osteoarthritis of the ankle. Orthop Clin N Am. 2019;50(4):529–537. doi: 10.1016/j.ocl.2019.05.008.
    1. Glazebrook M, Daniels T, Younger A, Foote CJ, Penner M, Wing K, Lau J, Leighton R, Dunbar M. Comparison of health-related quality of life between patients with end-stage ankle and hip arthrosis. J Bone Joint Surg Am. 2008;90(3):499–505. doi: 10.2106/JBJS.F.01299.
    1. Khlopas H, Khlopas A, Samuel LT, Ohliger E, Sultan AA, Chughtai M, Mont MA. Current concepts in osteoarthritis of the ankle: review. Surg Technol Int. 2019;35:280–294.
    1. Labek G, Thaler M, Janda W, Agreiter M, Stöckl B. Revision rates after total joint replacement: cumulative results from worldwide joint register datasets. J Bone Joint Surg Br. 2011;93:293–297. doi: 10.1302/0301-620X.93B3.25467.
    1. Spirt AA, Assal M, Hansen ST. Complications and failure after total ankle arthroplasty. J Bone Joint Surg Am. 2004;86(6):1172–1178. doi: 10.2106/00004623-200406000-00008.
    1. D’Ambrosi R, Banfi G, Usuelli FG. Total ankle arthroplasty and national registers: what is the impact on scientific production? Foot Ankle Surg. 2019;25(4):418–424. doi: 10.1016/j.fas.2018.02.016.
    1. Barg A, Elsner A, Anderson AE, Hintermann B. The effect of three-component total ankle replacement malalignment on clinical outcome: pain relief and functional outcome in 317 consecutive patients. J Bone Joint Surg Am. 2011;93:1969–1978. doi: 10.2106/JBJS.J.01415.
    1. Stamatis ED, Myerson MS. How to avoid specific complications of total ankle replacement. Foot Ankle Clin. 2002;7:765–789. doi: 10.1016/S1083-7515(02)00057-8.
    1. Hsu AR, Davis WH, Cohen BE, Jones CP, Ellington JK, Anderson RB. Radiographic outcomes of preoperative CT scan-derived patient-specific total ankle arthroplasty. Foot Ankle Int. 2015;36(10):1163–1169. doi: 10.1177/1071100715585561.
    1. Daigre J, Berlet G, Van Dyke B, Peterson KS, Santrock R. Accuracy and reproducibility using patient-specific instrumentation in total ankle arthroplasty. Foot Ankle Int. 2017;38(4):412–418. doi: 10.1177/1071100716682086.
    1. Berlet GC, Penner MJ, Lancianese S, Stemniski PM, Obert RM. Total ankle arthroplasty accuracy and reproducibility using preoperative CT scan-derived, patient-specific guides. Foot Ankle Int. 2014;35(7):665–676. doi: 10.1177/1071100714531232.
    1. Leardini A, O’Connor JJ, Giannini S. Biomechanics of the natural, arthritic, and replaced human ankle joint. J Foot Ankle Res. 2014;7(1):8. doi: 10.1186/1757-1146-7-8.
    1. Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001;8:1153–1157. doi: 10.1111/j.1553-2712.2001.tb01132.x.
    1. Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item health survey 1.0. Health Econ. 1993;2:217–227. doi: 10.1002/hec.4730020305.
    1. Ibrahim T, Beiri A, Azzabi M, Best AJ, Taylor GJ, Menon DK. Reliability and validity of the subjective component of the American Orthopaedic Foot and Ankle Society clinical rating scales. J Foot Ankle Surg. 2007;46:65–74. doi: 10.1053/j.jfas.2006.12.002.
    1. Leardini A, Catani F, Giannini S, O’Connor JJ. Computer-assisted design of the sagittal shapes of a ligament-compatible total ankle replacement. Med Biol Eng Comp. 2001;39:168–175. doi: 10.1007/BF02344799.
    1. Leardini A, Sawacha Z, Paolini G, Ingrosso S, Nativo R, Benedetti MG. A new anatomically based protocol for gait analysis in children. Gait Posture. 2007;26(4):560–571. doi: 10.1016/j.gaitpost.2006.12.018.
    1. Giannini S, Romagnoli M, O’Connor JJ, Malerba F, Leardini A. Total ankle replacement compatible with ligament function produces mobility, good clinical scores, and low complication rates: an early clinical assessment. Clin Orthop Relat Res. 2010;468(10):2746–2753. doi: 10.1007/s11999-010-1432-3.
    1. Syed F, Ugwuoke A. Ankle arthroplasty: A review and sumary of results from joint registries and recent studies. EFORT Open Rev. 2018;3(6):391–397. doi: 10.1302/2058-5241.3.170029.
    1. Saltzman CL, Tochigi Y, Rudert MJ, McIff TE, Brown TD. The effect of agility ankle prosthesis misalignment on the peri-ankle ligaments. Clin Orthop Relat Res. 2004;424:137–142. doi: 10.1097/01.blo.0000132463.80467.65.
    1. Sopher RS, Amis AA, Calder JD, Jeffers JRT. Total ankle replacement design and positioning affect implant-bone micromotion and bone strains. Med Eng Phys. 2017;42:80–90. doi: 10.1016/j.medengphy.2017.01.022.
    1. Fukuda T, Haddad SL, Ren Y, Zhang LQ. Impact of talar component rotation on contact pressure after total ankle arthroplasty: a cadaveric study. Foot Ankle Int. 2010;31(5):404–411. doi: 10.3113/FAI.2010.0404.
    1. Kakkar R, Siddique MS. Stresses in the ankle joint and total ankle replacement design. Foot Ankle Surg. 2011;17(2):58–63. doi: 10.1016/j.fas.2011.02.002.
    1. Saito GH, Sanders AE, O’Malley MJ, Deland JT, Ellis SJ, Demetracopoulos CA. Accuracy of patient-specific instrumentation in total ankle arthroplasty: a comparative study. Foot Ankle Surg. 2019;25(3):383–389. doi: 10.1016/j.fas.2018.02.008.
    1. Shane A, Sahli H. Total ankle replacement options. Clin Podiatr Med Surg. 2019;36(4):597–607. doi: 10.1016/j.cpm.2019.06.005.
    1. Giannini S, Romagnoli M, O’Connor JJ, Catani F, Nogarin L, Magnan B, Malerba F, Massari L, Guelfi M, Milano L, Volpe A, Rebeccato A, Leardini A. Early clinical results of the BOX ankle replacement are satisfactory: a multicenter feasibility study of 158 ankles. J Foot Ankle Surg. 2011;50(6):641–647. doi: 10.1053/j.jfas.2011.06.003.
    1. Hamid KS, Matson AP, Nwachukwu BU, Scott DJ, Mather RC, DeOrio JK. Determining the cost-savings threshold and alignment accuracy of patient specific instrumentation in total ankle replacements. Foot Ankle Int. 2016;38:49–57. doi: 10.1177/1071100716667505.
    1. Belvedere C, Siegler S, Fortunato A, Caravaggi P, Liverani E, Durante S, Ensini A, Konow T, Leardini A. New comprehensive procedure for custom-made total ankle replacements: Medical imaging, joint modeling, prosthesis design, and 3D printing. J Orthop Res. 2019;37(3):760–768. doi: 10.1002/jor.24198.

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