Comparison of Customized and Standard Total Ankle Prostheses
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 24 people, planned
- Started
- 26 Jul 2023
- Expected to end
- 26 Apr 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Total ankle arthroplasty
- Record updated
- 29 December 2025
Who can take part
- Age
- 40 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients that requires ancillary surgical procedures
- Social conditions (homeless patients, with restrictions on personal freedom)
- Deep venous insufficiency Lower limbs
- History of Erisipelas lower limbs
- Neurological or psychocognitive disorders
- neurological diseases
- Personal or family history of DVT or EP
- Patients with rheumatic diseases
- ASA 3 and 4
- Axial deformities of ankle >15°
- Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)
- Pregnant women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- TraditionalExisting treatment, for comparison
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: Total ankle arthroplasty
- CustomTreatment being tested
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: Total ankle arthroplasty
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study
- Fit questions
- Built from NCT06193057, who can take part
- Record updated
- 29 December 2025