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New treatment option for Ankle Osteoarthritis
Official title Comparison of Customized and Standard Total Ankle Prostheses
ClinicalTrials.gov ID: NCT06193057
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Male and female people older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- Male and female people 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, BO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, BO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.