Comparison of Customized and Standard Total Ankle Prostheses

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Ankle Osteoarthritis

Treatments: Procedure: Total ankle arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06193057

3POD-TAR

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Traditional

Active Comparator group

Description:

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)

Treatment:

Procedure: Total ankle arthroplasty

Custom

Experimental group

Description:

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.

Treatment:

Procedure: Total ankle arthroplasty