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

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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. Case report.

Related collections

Most cited references 26

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Revision rates after total joint replacement: cumulative results from worldwide joint register datasets.

G Labek, M THALER, W Janda … (2011)

In a systematic review, reports from national registers and clinical studies were identified and analysed with respect to revision rates after joint replacement, which were calculated as revisions per 100 observed component years. After primary hip replacement, a mean of 1.29 revisions per 100 observed component years was seen. The results after primary total knee replacement are 1.26 revisions per 100 observed component years, and 1.53 after medial unicompartmental replacement. After total ankle replacement a mean of 3.29 revisions per 100 observed component years was seen. The outcomes of total hip and knee replacement are almost identical. Revision rates of about 6% after five years and 12% after ten years are to be expected.

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Reliability and validity of the subjective component of the American Orthopaedic Foot and Ankle Society clinical rating scales.

Talal Ibrahim, Almoghera Beiri, Mohamed Azzabi … (2015)

This study evaluates the criterion validity of the subjective component of the American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating scales by correlating scores obtained with these rating scales to scores obtained with the Foot Function Index (FFI) in patients with foot and ankle conditions. To date, the AOFAS scoring scales have not been shown to provide valid information despite their popularity. The FFI, on the other hand, has previously been shown to provide valid information in regard to conditions affecting the foot and ankle. A moderately strong inverse criterion validity correlation (Pearson correlation coefficient = -0.68) was shown when preoperative patients were administered both the AOFAS and FFI questionnaires, and the resultant scores were compared. Test-retest reliability measurements showed no significant difference (P = .27) between preoperative AOFAS scale scores measured at least 2 weeks apart. Construct validity was shown (P = .006) when dependent preoperative and postoperative (at least 3 months) AOFAS scale scores were compared, indicative of the clinical rating scales' ability to discriminate and predict quality of life related to foot and ankle conditions. The moderate level of correlation, satisfactory degree of reliability, and responsiveness (ability to distinguish differences between preoperative and postoperative conditions in the same patient) observed in this study suggest that the subjective component of the AOFAS clinical rating scales provides quality-of-life information that conveys acceptable validity regarding conditions affecting the foot and ankle.

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Comparison of health-related quality of life between patients with end-stage ankle and hip arthrosis.

Julie T. Daniels, Ross K Leighton, M Penner … (2008)

End-stage ankle arthrosis is one of the leading causes of chronic disability in North America. Information on this condition is limited. The amount of pain and the reduction in health-related quality of life and function have not been quantified with use of universal outcome measures. The purpose of the present study was to compare the extent of pain, loss of function, and health-related quality of life in two cohorts of patients waiting for the surgical treatment of end-stage ankle or hip arthrosis. One hundred and thirty patients with end-stage ankle arthrosis who were awaiting total ankle arthroplasty or ankle arthrodesis were recruited through a Canadian Orthopaedic Foot and Ankle Society multicenter study. All patients prospectively completed the Short Form-36 (SF-36) generic outcome instrument. This cohort was compared with a similar cohort of 130 patients with end-stage hip arthrosis, randomly selected from an existing prospective joint replacement database, who had completed an SF-36 questionnaire prospectively from 2000 to 2005. In both groups, the scores for all SF-36 subscales were approximately two standard deviations below normal population scores. Patients with ankle arthrosis had significantly worse mental component summary scores (p < 0.05), role-physical scores (p < 0.05), and general health scores (p < 0.05). Patients with hip arthrosis reported significantly lower physical function scores (p < 0.05), although the SF-36 physical component summary score was not significantly different between the two groups. The SF-36 physical component summary, bodily pain, vitality, role-emotional, social functioning, and mental health subscale scores were equally affected in both cohorts. The mental and physical disability associated with end-stage ankle arthrosis is at least as severe as that associated with end-stage hip arthrosis.

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Author and article information

Contributors

A. Mazzotti:

ORCID: http://orcid.org/0000-0001-9974-4787

antonio.mazzotti@ior.it

Journal

Journal ID (nlm-ta): J Orthop Traumatol

Journal ID (iso-abbrev): J Orthop Traumatol

Title: Journal of Orthopaedics and Traumatology : Official Journal of the Italian Society of Orthopaedics and Traumatology

Publisher: Springer International Publishing (Cham )

ISSN (Print): 1590-9921

ISSN (Electronic): 1590-9999

Publication date (Electronic): 2 September 2020

Publication date PMC-release: 2 September 2020

Publication date (Print): December 2020

Volume: 21

Electronic Location Identifier: 16

Affiliations

[1 ]GRID grid.419038.7, ISNI 0000 0001 2154 6641, 1st Orthopaedic and Traumatologic Clinic, , IRCCS Istituto Ortopedico Rizzoli, ; Via Giulio Cesare Pupilli 1, 40136 Bologna, Italy

[2 ]GRID grid.6292.f, ISNI 0000 0004 1757 1758, Department of Biomedical and Neuromotor Sciences, , University of Bologna, ; 40123 Bologna, Italy

[3 ]GRID grid.419038.7, ISNI 0000 0001 2154 6641, Movement Analysis Laboratory, , IRCCS Istituto Ortopedico Rizzoli, ; Via Giulio Cesare Pupilli 1, 40136 Bologna, Italy

Author information

A. Mazzotti http://orcid.org/0000-0001-9974-4787

Article

Publisher ID: 555

DOI: 10.1186/s10195-020-00555-7

PMC ID: 7468019

PubMed ID: 32876778

SO-VID: 29c583d6-d217-4947-bc8e-ae0f359a9eb7

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 7 April 2020

Date accepted : 29 July 2020

Custom metadata

ScienceOpen disciplines: Orthopedics

Keywords: custom-made implant,3d-printing,total ankle arthroplasty,total ankle replacement,psi,surgical treatment

Data availability:

ScienceOpen disciplines: Orthopedics

Keywords: custom-made implant, 3d-printing, total ankle arthroplasty, total ankle replacement, psi, surgical treatment

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

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Abstract

Background

Case presentation

Conclusions

Level of evidence

Related collections

Orthopedics

Most cited references 26

Revision rates after total joint replacement: cumulative results from worldwide joint register datasets.

Reliability and validity of the subjective component of the American Orthopaedic Foot and Ankle Society clinical rating scales.

Comparison of health-related quality of life between patients with end-stage ankle and hip arthrosis.

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Contributors

Journal

Affiliations

Author information

Article

History

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