CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conventional total knee arthroplasty, computer-assisted total knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Knee Arthroplasty, Total. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
Overview
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.
Interventions
- Procedure conventional total knee arthroplasty
total knee arthroplasty performed with conventional technique - Procedure computer-assisted total knee arthroplasty
total knee arthroplasty performed with imageless computer-assisted surgery
Primary outcome measures
- Knee Society Score (KSS) [Time frame: From enrollment to 12 months post-operative followup]
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: from enrollment to 12 months post-operative followup]
- NRS scale [Time frame: from enrollment to 12 months post-operative followup]
Secondary outcome measures (5)
- surgical time [Time frame: the day of surgical procedure]
- complications [Time frame: from surgery to 12 month follow-up]
- delta hemoglobin [Time frame: from surgery to discharge, up to 4 weeks]
- Transfusions [Time frame: from surgery to discharge, up to 4 weeks]
- hospital stay [Time frame: from surgery to discharge, up to 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06608745 · CE-AVEC 572/2023/Sper/IOR