Comparison of Customized and Standard Total Ankle Prostheses
ConditionAnkle Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorIstituto Ortopedico Rizzoli
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Social conditions (homeless patients, with restrictions on personal freedom)
ASA 3 and 4
Deep venous insufficiency Lower limbs
History of Erisipelas lower limbs
Trial design
Treatments tested in this trial
- Total ankle arthroplasty
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov