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Comparison of Customized and Standard Total Ankle Prostheses
Sponsor: Istituto Ortopedico Rizzoli
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
Official title: Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2023-07-26
Completion Date
2027-04-26
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Rizzoli Orthopaedic Institute
Bologna, BO, Italy