Comparison of Customized and Standard Total Ankle Prostheses
Recruiting · NCT06193057 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
Total ankle arthroplasty
What this trial is about
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
Who can take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Rizzoli Orthopaedic Institute - Bologna, BO, Italy