Comparison of Customized and Standard Total Ankle Prostheses

NCT06193057 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Ortopedico Rizzoli

Phase

Not applicable

Started

2023-07-26

Last updated

2025-12-29

Condition(s) studied

Ankle Osteoarthritis

Investigational drug(s) / intervention(s)

Total ankle arthroplasty

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.

Study 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

Eligibility

Sex

ALL

Min age

40 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Ankle radiographic angles — at baseline (day 0)
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.
Ankle radiographic angles — 3 months
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.
Ankle radiographic angles — 6 months
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.
Ankle radiographic angles — 12 months
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.
Ankle radiographic angles — 18 months
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.

Trial sites (1)

Facility	City	Region	Status
Rizzoli Orthopaedic Institute	Bologna	BO	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06193057 on ClinicalTrials.gov ↗ ← All trials in Italy