Comparison of Customized and Standard Total Ankle Prostheses

Official title

Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study

Overview

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

Interventions

• Procedure 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 component

Primary outcome measures

• Ankle radiographic angles [Time frame: at baseline (day 0)]
• Ankle radiographic angles [Time frame: 3 months]
• Ankle radiographic angles [Time frame: 6 months]
• Ankle radiographic angles [Time frame: 12 months]
• Ankle radiographic angles [Time frame: 18 months]

Secondary outcome measures (12)

• Short form 12 [Time frame: at baseline (day 0)]
• Short form 12 [Time frame: 3 months]
• Short form 12 [Time frame: 6 months]
• Short form 12 [Time frame: 12 months]
• Short form 12 [Time frame: 18 months]
• Visual Analogic Scale [Time frame: at baseline (day 0)]
• Visual Analogic Scale [Time frame: 3 months]
• Visual Analogic Scale [Time frame: 6 months]
• Visual Analogic Scale [Time frame: 12 months]
• Visual Analogic Scale [Time frame: 18 months]
• American Orthopedic Foot and Ankle Score [Time frame: at baseline (day 0)]
• American Orthopedic Foot and Ankle Score [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Rizzoli Orthopaedic Institute — Bologna

Publications

• 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
• 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
• 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
• 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
• 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'Donn PMID 36375147
• 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
• 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
• 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

Identifiers

NCT: NCT06193057 · 3POD-TAR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗