Comparison of Customized and Standard Total Ankle Prostheses

Not Applicable

Recruiting

• Conditions: Ankle Osteoarthritis
• Interventions: Procedure: Total ankle arthroplasty

• Registration Number: NCT06193057
• Lead Sponsor: Istituto Ortopedico Rizzoli

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-26
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-05-31
• Study Completion: 2026-07-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional	Total ankle arthroplasty	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)
Custom	Total ankle arthroplasty	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Short form 12	18 months	The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
Visual Analogic Scale	18 months	Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Ankle Range of motion	18 months	Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.
American Orthopedic Foot and Ankle Score	18 months	The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, BO, Italy