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

NCT06608745 | Recruiting

• 1 other identifier: CE-AVEC 572/2023/Sper/IOR
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  from enrollment to 12 months post-operative followup

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Interventions

conventional total knee arthroplasty PROCEDURE

total knee arthroplasty performed with conventional technique

conventional total knee arthroplasty surgery

computer-assisted total knee arthroplasty PROCEDURE

total knee arthroplasty performed with imageless computer-assisted surgery

computer-assisted total knee arthroplasty surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Central Study Contacts

Dallari (M.D.)

CONTACT

39+0516366252; dante.dallari@ior.it

Haddad (M.D.)

CONTACT

39+0516366252; dario.haddad@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 23, 2024
• Study Start: February 12, 2024
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

IT (1)