CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results
- Conditions
- Knee Arthroplasty, Total
- Interventions
- Procedure: conventional total knee arthroplastyProcedure: computer-assisted total knee arthroplasty
- Registration Number
- NCT06608745
- Lead Sponsor
- Istituto Ortopedico Rizzoli
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional total knee arthroplasty surgery conventional total knee arthroplasty - computer-assisted total knee arthroplasty surgery computer-assisted total knee arthroplasty -
- Primary Outcome Measures
Name Time Method 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 conditionsWestern 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
- Secondary Outcome Measures
Name Time Method surgical time the day of surgical procedure complications from surgery to 12 month follow-up using Clavien Dindo classification of surgical complications
delta hemoglobin 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
Transfusions 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
hospital stay from surgery to discharge, up to 4 weeks days of hospital stay from surgery to discharge
Trial Locations
- Locations (1)
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy