Comparison of Custom and Standard Total Knee Replacements

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

December 30, 2025

Study Completion Date

April 30, 2026

Conditions
Knee Osteoarthritis
Interventions
PROCEDURE

total knee arthroplasty

In detail, in the STANDARD group, patients will undergo a primary TKR by implanting a prosthetic model of the same standard design for all using the usual surgical technique and instrumentation (based on the use of guide intramedullary of femur and extramedullary of tibia); in the PERSONALIZED group, patients will undergo a primary TKA by implanting a prosthetic model (YourKnee, Rejoint) with design based specifically on each patient's actual knee morphology and using PSI surgical technique and instrumentation. In both groups, the approach of the basic prosthetic design base will be of the Cruciate-Retaining (CR) type with congruent polyethylene (PE), with standard and customized for the STANDARD and CUSTOM group, respectively.

Trial Locations (1)

40136

RECRUITING

IRCCS Istituto Ortopedico Rizzoli, Bologna

All Listed Sponsors
lead

Istituto Ortopedico Rizzoli

OTHER