CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results (CAS-K)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Procedure: conventional total knee arthroplasty; Procedure: computer-assisted total knee arthroplasty

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dallari (M.D.); Phone Number: 39+0516366252; Email: dante.dallari@ior.it
• Study Contact Backup: Name: Haddad (M.D.); Phone Number: 39+0516366252; Email: dario.haddad@ior.it

Study Locations

• Italy
  • Bologna, Italy
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Dallari (M.D.); Phone Number: 39+0516366252; Email: dante.dallari@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional total knee arthroplasty surgery	Procedure: conventional total knee arthroplasty; total knee arthroplasty performed with conventional technique
Experimental: computer-assisted total knee arthroplasty surgery	Procedure: computer-assisted total knee arthroplasty; total knee arthroplasty performed with imageless computer-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score (KSS)	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	From enrollment to 12 months post-operative followup
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	from enrollment to 12 months post-operative followup
NRS scale	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	from enrollment to 12 months post-operative followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical time		the day of surgical procedure
complications	using Clavien Dindo classification of surgical complications	from surgery to 12 month follow-up
delta hemoglobin	For each patient blood loss will be assessed by measuring the difference in hemoglobin (g/dL) on the preoperative blood sample VS last blood sample before discharge	from surgery to discharge, up to 4 weeks
Transfusions	It will be accounted the number of blood transfusions that patients may need during the hospital stay until discharge	from surgery to discharge, up to 4 weeks
hospital stay	days of hospital stay from surgery to discharge	from surgery to discharge, up to 4 weeks

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CE-AVEC 572/2023/Sper/IOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes