Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Rizzoli Orthopaedic Institute
RECRUITING
Bologna
Contact Information
Primary
massimiliano mosca, MD
massimiliano.mosca@ior.it
0516366
Backup
silvio caravelli, MD
silvio.caravelli@ior.it
0516366
Time Frame
Start Date: 2023-07-26
Estimated Completion Date: 2026-07-26
Participants
Target number of participants: 24
Treatments
Active_comparator: Traditional
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)
Experimental: Custom
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.
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov