RecruitingNot ApplicableNCT06608745

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

CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

160 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 Years

Inclusion Criteria4

  • Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant
  • Males and females aged ≥ 45
  • Willingness to participate in the study
  • Acquisition of informed consent to participate

Exclusion Criteria4

  • Patients who are not capable of understanding and willing, and therefore unable to express 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

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Interventions

PROCEDUREconventional total knee arthroplasty

total knee arthroplasty performed with conventional technique

PROCEDUREcomputer-assisted total knee arthroplasty

total knee arthroplasty performed with imageless computer-assisted surgery


Locations(1)

Istituto Ortopedico Rizzoli

Bologna, Italy

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NCT06608745


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