Status:
RECRUITING
Comparison of Customized and Standard Total Ankle Prostheses
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Ankle Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
NA
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 recon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 26 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06193057
Start Date
July 26 2023
End Date
April 26 2027
Last Update
December 29 2025
Active Locations (1)
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1
Rizzoli Orthopaedic Institute
Bologna, BO, Italy, 40126