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NCT Number: NCT06608745

CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, Italy

Location status: Recruiting

Location contact

Dallari (M.D.)

CONTACT

[email protected]

39+0516366252

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional total knee arthroplasty

Procedure

total knee arthroplasty performed with conventional technique

computer-assisted total knee arthroplasty

Procedure

total knee arthroplasty performed with imageless computer-assisted surgery

Primary outcomes

  1. 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

  2. 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.

  3. 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

  1. surgical time

    Time frame: the day of surgical procedure

  2. complications

    Time frame: from surgery to 12 month follow-up

    using Clavien Dindo classification of surgical complications

  3. delta hemoglobin

    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

  4. Transfusions

    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

  5. hospital stay

    Time frame: from surgery to discharge, up to 4 weeks

    days of hospital stay from surgery to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Dallari (M.D.)

CONTACT

[email protected]

39+0516366252

Haddad (M.D.)

CONTACT

[email protected]

39+0516366252

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali

Acronym: CAS-K

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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