NCT06193057

Comparison of Customized and Standard Total Ankle Prostheses

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2023-07-26
• Primary completion: 2026-04-30
• Completion: 2027-04-26
• First posted: 2024-01-05
• Last updated: 2025-12-29

Locations

1 site across 1 country: Italy