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Clinical Trials in Italy / NCT06608745
Recruiting Not applicable

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

NCT06608745 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2024-02-12
Last updated
2025-09-22

Condition(s) studied

Knee Arthroplasty, Total

Investigational drug(s) / intervention(s)

conventional total knee arthroplastycomputer-assisted total knee arthroplasty

conventional total knee arthroplasty: total knee arthroplasty performed with conventional technique

computer-assisted total knee arthroplasty: total knee arthroplasty performed with imageless computer-assisted surgery

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

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Knee Society Score (KSS) — From enrollment to 12 months post-operative followup
    Knee Society Clinical Rating System (KSS): there are 2 section, "Knee Score" section and a "Functional Score" section; both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — from enrollment to 12 months post-operative followup
    Set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The score measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations.
  • NRS scale — from enrollment to 12 months post-operative followup
    Numeric Pain Rating scale is a unidimensional measure of pain in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. 0 = no pain, 10 = worst pain possible

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06608745 on ClinicalTrials.gov ↗ ← All trials in Italy