Knee Arthroplasty, TotalCAS-KNCT06608745
CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results
A study testing conventional total knee arthroplasty and computer-assisted total knee arthroplasty in people with Knee Arthroplasty, Total, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- conventional total knee arthroplasty and computer-assisted total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2024to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna
Dallari (M.D.), 39+0516366252, dante.dallari@ior.it
About this study
Official title: CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
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.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- conventional total knee arthroplasty, computer-assisted total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional total knee arthroplastyProcedure or surgery
total knee arthroplasty performed with conventional technique
computer-assisted total knee arthroplastyProcedure or surgery
total knee arthroplasty performed with imageless computer-assisted surgery
| Study group | Role | What they receive |
|---|---|---|
| conventional total knee arthroplasty surgery | Active comparator | Not described Receives: Procedure: conventional total knee arthroplasty |
| computer-assisted total knee arthroplasty surgery | Experimental | Not described Receives: Procedure: computer-assisted total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 12 months post-operative followup
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.
Measured: from enrollment to 12 months post-operative followup
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
Measured: from enrollment to 12 months post-operative followup
Secondary outcomes (5)
surgical time
Measured: the day of surgical procedure
complications
using Clavien Dindo classification of surgical complications
Measured: from surgery to 12 month follow-up
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
Measured: from surgery to discharge, up to 4 weeks
Transfusions
It will be accounted the number of blood transfusions that patients may need during the hospital stay until discharge
Measured: from surgery to discharge, up to 4 weeks
hospital stay
days of hospital stay from surgery to discharge
Measured: from surgery to discharge, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start12 Feb 2024
- Primary completion12 Aug 2026 (estimated)
- Study completion12 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608745
- Sponsor's protocol ID
- CE-AVEC 572/2023/Sper/IOR
- Acronym
- CAS-K
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
- ClinicalTrials.gov ID
- NCT06608745
- Acronym / sponsor ID
- CAS-K / CE-AVEC 572/2023/Sper/IOR
- Conditions
- Knee Arthroplasty, Total
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 12 Aug 2026 (estimated)
- Study completion
- 12 Aug 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional total knee arthroplasty surgery | Active comparator | Procedure: conventional total knee arthroplasty |
| computer-assisted total knee arthroplasty surgery | Experimental | Procedure: computer-assisted total knee arthroplasty |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional total knee arthroplastytotal knee arthroplasty performed with conventional technique | Procedure or surgery | conventional total knee arthroplasty surgery |
| computer-assisted total knee arthroplastytotal knee arthroplasty performed with imageless computer-assisted surgery | Procedure or surgery | computer-assisted total knee arthroplasty surgery |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional total knee arthroplasty and computer-assisted total knee arthroplasty in people with Knee Arthroplasty, Total, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dallari (M.D.) (39+0516366252, dante.dallari@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (KSS) (time frame: From enrollment to 12 months post-operative followup). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.