Istituto Ortopedico Rizzoli
Bologna, Italy
Location status: Recruiting
NCT Number: NCT06608745
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.
Interested in participating?
Request Info45 year and older
All sexes
Interventional
Not applicable
Bologna, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
total knee arthroplasty performed with conventional technique
total knee arthroplasty performed with imageless computer-assisted surgery
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: the day of surgical procedure
Time frame: from surgery to 12 month follow-up
using Clavien Dindo classification of surgical complications
Time frame: from surgery to discharge, up to 4 weeks
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 weeks
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 weeks
days of hospital stay from surgery to discharge
Contact information is provided by the study sponsor or research team.
Dallari (M.D.)
CONTACT
39+0516366252
Haddad (M.D.)
CONTACT
39+0516366252
Istituto Ortopedico Rizzoli
Other
CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
Acronym: CAS-K
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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