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CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results (CAS-K)

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Knee Arthroplasty, Total

Treatments

Procedure: conventional total knee arthroplasty
Procedure: computer-assisted total knee arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT06608745
CE-AVEC 572/2023/Sper/IOR

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 2 patient groups

conventional total knee arthroplasty surgery
Active Comparator group
Treatment:
Procedure: conventional total knee arthroplasty
computer-assisted total knee arthroplasty surgery
Experimental group
Treatment:
Procedure: computer-assisted total knee arthroplasty

Trial contacts and locations

1

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Central trial contact

Haddad (M.D.); Dallari (M.D.)

Data sourced from clinicaltrials.gov

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