CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Knee Society Score (KSS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
conventional total knee arthroplasty surgery
Intervention: conventional total knee arthroplasty (Procedure)
computer-assisted total knee arthroplasty surgery
Intervention: computer-assisted total knee arthroplasty (Procedure)
Outcomes
Primary Outcomes
Knee Society Score (KSS)
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
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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.
NRS scale
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
Secondary Outcomes
- surgical time(the day of surgical procedure)
- complications(from surgery to 12 month follow-up)
- delta hemoglobin(from surgery to discharge, up to 4 weeks)
- Transfusions(from surgery to discharge, up to 4 weeks)
- hospital stay(from surgery to discharge, up to 4 weeks)