CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results

Last updated: September 19, 2025
Sponsor: Istituto Ortopedico Rizzoli
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

computer-assisted total knee arthroplasty

conventional total knee arthroplasty

Clinical Study ID

NCT06608745
CE-AVEC 572/2023/Sper/IOR
  • Ages > 45
  • All Genders

Study Summary

The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation.

The comparison between the two techniques will be performed in terms of clinical-functional results, perioperative bleeding and healthcare costs (surgical time, hospital stay).

The research protocol involves the participation of 160 total patients divided into two groups, of 80 patients each, by type of surgical technique.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with primary or secondary gonarthrosis with indication for kneearthroplasty with primary implant

  • Males and females aged ≥ 45

  • Willingness to participate in the study

  • Acquisition of informed consent to participate

Exclusion

Exclusion Criteria:

  • Patients who are not capable of understanding and willing, and therefore unable toexpress consent to participation in the study

  • Patient refusal to participate in the study and to sign the informed consent

  • Nickel allergy (suspected or diagnosed)

  • Pregnant women or women of childbearing age who cannot exclude pregnancy

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: computer-assisted total knee arthroplasty
Phase:
Study Start date:
February 12, 2024
Estimated Completion Date:
August 12, 2026

Connect with a study center

  • Istituto Ortopedico Rizzoli

    Bologna,
    Italy

    Site Not Available

  • Istituto Ortopedico Rizzoli

    Bologna 3181928,
    Italy

    Active - Recruiting

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