Comparison of Customized and Standard Total Ankle Prostheses
NCT ID: NCT06193057
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2023-07-26
2027-04-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Traditional
In the STANDARD group, patients will undergo a primary TAR by implanting a prosthetic model of a standard design, that is the same for all using the usual surgical technique and instrumentation (based on the use of external leg guidance)
Total ankle arthroplasty
Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.
Custom
In the PERSONALIZED group, patients will undergo a primary TAR by implanting a prosthetic model with a design specifically based on each patient's actual ankle morphology and using PSI surgical technique and instrumentation.
Total ankle arthroplasty
Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.
Interventions
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Total ankle arthroplasty
Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consenting patients and able to complete scheduled study procedures and follow-up evaluations.
* Patients who have signed the "informed consent" approved by the Ethics Committee.
Exclusion Criteria
* ASA 3 and 4
* Deep venous insufficiency Lower limbs
* History of Erisipelas lower limbs
* Neurological or psychocognitive disorders
* neurological diseases
* Axial deformities of ankle \>15°
* Personal or family history of DVT or EP
* Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)
* Pregnant women
* Patients with rheumatic diseases
* Patients that requires ancillary surgical procedures
40 Years
75 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Rizzoli Orthopaedic Institute
Bologna, BO, Italy
Countries
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Central Contacts
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Facility Contacts
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Massimiliano Mosca
Role: primary
References
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Malerba F, Benedetti MG, Usuelli FG, Milani R, Berti L, Champlon C, Leardini A. Functional and clinical assessment of two ankle arthrodesis techniques. J Foot Ankle Surg. 2015 May-Jun;54(3):399-405. doi: 10.1053/j.jfas.2014.09.007. Epub 2014 Nov 26.
Shane A, Sahli H. Total Ankle Replacement Options. Clin Podiatr Med Surg. 2019 Oct;36(4):597-607. doi: 10.1016/j.cpm.2019.06.005.
Foran IM, Vafek EC, Bohl DD, Lee S, Hamid KS. Quality Assessment of Modern Total Ankle Arthroplasty Clinical Outcomes Research. J Foot Ankle Surg. 2022 Jan-Feb;61(1):7-11. doi: 10.1053/j.jfas.2021.05.011. Epub 2021 Jun 10.
Mosca M, Caravelli S, Vocale E, Massimi S, Censoni D, Di Ponte M, Fuiano M, Zaffagnini S. Clinical Radiographical Outcomes and Complications after a Brand-New Total Ankle Replacement Design through an Anterior Approach: A Retrospective at a Short-Term Follow Up. J Clin Med. 2021 May 23;10(11):2258. doi: 10.3390/jcm10112258.
Goldberg AJ, Chowdhury K, Bordea E, Hauptmannova I, Blackstone J, Brooking D, Deane EL, Bendall S, Bing A, Blundell C, Dhar S, Molloy A, Milner S, Karski M, Hepple S, Siddique M, Loveday DT, Mishra V, Cooke P, Halliwell P, Townshend D, Skene SS, Dore CJ; TARVA Study Group; Brown R, Butler M, Chadwick C, Clough T, Cullen N, Davies M, Davies H, Harries B, Khoo M, Makwana N, Murty A, Najefi A, O'Donnell P, Raglan M, Thomas R, Torres P, Welck M, Winson I, Zaidi R. Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis: A Randomized Controlled Trial. Ann Intern Med. 2022 Dec;175(12):1648-1657. doi: 10.7326/M22-2058. Epub 2022 Nov 15.
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 Mar;37(3):760-768. doi: 10.1002/jor.24198. Epub 2019 Jan 3.
Faldini C, Mazzotti A, Belvedere C, Durastanti G, Panciera A, Geraci G, Leardini A. A new ligament-compatible patient-specific 3D-printed implant and instrumentation for total ankle arthroplasty: from biomechanical studies to clinical cases. J Orthop Traumatol. 2020 Sep 2;21(1):16. doi: 10.1186/s10195-020-00555-7.
Mazzotti A, Arceri A, Zielli S, Bonelli S, Viglione V, Faldini C. Patient-specific instrumentation in total ankle arthroplasty. World J Orthop. 2022 Mar 18;13(3):230-237. doi: 10.5312/wjo.v13.i3.230. eCollection 2022 Mar 18.
Brinkmann EJ, Fitz W. Custom total knee: understanding the indication and process. Arch Orthop Trauma Surg. 2021 Dec;141(12):2205-2216. doi: 10.1007/s00402-021-04172-9. Epub 2021 Oct 15.
Leardini A, Belvedere C, de Cesar Netto C. Total Ankle Replacement: Biomechanics of the Designs, Clinical Outcomes, and Remaining Issues. Foot Ankle Clin. 2023 Mar;28(1S):e1-e14. doi: 10.1016/j.fcl.2023.01.001. Epub 2023 Mar 1.
Ferraro D, Siegler S, Belvedere C, Ruiz M, Leardini A. Effect of artificial surface shapes and their malpositioning on the mechanics of the replaced ankle joint for possible better prosthesis designs. Clin Biomech (Bristol). 2021 Dec;90:105489. doi: 10.1016/j.clinbiomech.2021.105489. Epub 2021 Sep 17.
Pavani C, Belvedere C, Ortolani M, Girolami M, Durante S, Berti L, Leardini A. 3D measurement techniques for the hindfoot alignment angle from weight-bearing CT in a clinical population. Sci Rep. 2022 Oct 7;12(1):16900. doi: 10.1038/s41598-022-21440-9.
Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.
Boeckstyns MEH, Backer M. Reliability and validity of the evaluation of pain in patients with total knee replacement. Pain. 1989 Jul;38(1):29-33. doi: 10.1016/0304-3959(89)90069-9.
Hagell P, Westergren A, Arestedt K. Beware of the origin of numbers: Standard scoring of the SF-12 and SF-36 summary measures distorts measurement and score interpretations. Res Nurs Health. 2017 Aug;40(4):378-386. doi: 10.1002/nur.21806.
Other Identifiers
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3POD-TAR
Identifier Type: -
Identifier Source: org_study_id