Comparison of Customized and Standard Total Ankle Prostheses

NCT06193057 | Recruiting

• 1 other identifier: 3POD-TAR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures

Conditions

Ankle Osteoarthritis

Keywords

replacement; customized; TAR; arthroplasty; radiographic angles; clinical scores

Outcome Measures

Primary Outcomes (5)

• Ankle radiographic angles

  Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.

  at baseline (day 0)

• Ankle radiographic angles

  Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.

  3 months

• Ankle radiographic angles

  Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.

  6 months

• Ankle radiographic angles

  Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.

  12 months

• Ankle radiographic angles

  Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.

  18 months

Secondary Outcomes (20)

• Short form 12

  at baseline (day 0)

• Short form 12

  3 months

• Short form 12

  6 months

• Short form 12

  12 months

• Short form 12

  18 months

Study Arms (2)

Traditional

ACTIVE COMPARATOR

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)

Procedure: Total ankle arthroplasty

Custom

EXPERIMENTAL

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.

Procedure: Total ankle arthroplasty

Interventions

Total ankle arthroplasty PROCEDURE

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.

Also known as: Total ankle arthroplasty with anterior approach

Custom; Traditional

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement.
• 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.

You may not qualify if:

• Social conditions (homeless patients, with restrictions on personal freedom)
• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, BO, 40126, Italy

RECRUITING

Related Publications (15)

• 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.

  PMID: 31466570 RESULT

• 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.

  PMID: 34244049 RESULT

• 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.

  PMID: 34071032 RESULT

• 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.

  PMID: 25434867 RESULT

• 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.

  PMID: 36375147 RESULT

• 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.

  PMID: 30537247 RESULT

• 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.

  PMID: 32876778 RESULT

• 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.

  PMID: 35317257 RESULT

• 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.

  PMID: 34652517 RESULT

• 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.

  PMID: 36935170 RESULT

• 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.

  PMID: 34560346 RESULT

• 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.

  PMID: 36207422 RESULT

• 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.

  PMID: 7951968 RESULT

• 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.

  PMID: 2780060 RESULT

• 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.

  PMID: 28732149 RESULT

MeSH Terms

Interventions

Arthroplasty, Replacement, Ankle

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

massimiliano mosca, MD

CONTACT

0516366; massimiliano.mosca@ior.it

silvio caravelli, MD

CONTACT

0516366; silvio.caravelli@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: July 26, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 26, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)