CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results
ConditionKnee Arthroplasty, Total
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorIstituto Ortopedico Rizzoli
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
conventional total knee arthroplasty
Procedure/Surgerytotal knee arthroplasty performed with conventional technique
computer-assisted total knee arthroplasty
Procedure/Surgerytotal knee arthroplasty performed with imageless computer-assisted surgery
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: conventional total knee arthroplasty surgeryActive comparator 1 intervention
Group B: computer-assisted total knee arthroplasty surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to 12 months post-operative followup2
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.
Time frame
from enrollment to 12 months post-operative followup3
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
Time frame
from enrollment to 12 months post-operative followupSecondary outcomes
1
surgical time
Time frame
the day of surgical procedure2
complications
using Clavien Dindo classification of surgical complications
Time frame
from surgery to 12 month follow-up3
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
Time frame
from surgery to discharge, up to 4 weeks4
Transfusions
It will be accounted the number of blood transfusions that patients may need during the hospital stay until discharge
Time frame
from surgery to discharge, up to 4 weeksSponsors and contacts
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Source ClinicalTrials.gov