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

NCT ID: NCT06608745

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2026-08-12

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Arthroplasty, Total

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional total knee arthroplasty surgery

Group Type ACTIVE_COMPARATOR

conventional total knee arthroplasty

Intervention Type PROCEDURE

total knee arthroplasty performed with conventional technique

computer-assisted total knee arthroplasty surgery

Group Type EXPERIMENTAL

computer-assisted total knee arthroplasty

Intervention Type PROCEDURE

total knee arthroplasty performed with imageless computer-assisted surgery

Interventions

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conventional total knee arthroplasty

total knee arthroplasty performed with conventional technique

Intervention Type PROCEDURE

computer-assisted total knee arthroplasty

total knee arthroplasty performed with imageless computer-assisted surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Dallari (M.D.)

Role: CONTACT

39+0516366252

Haddad (M.D.)

Role: CONTACT

39+0516366252

Facility Contacts

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Dallari (M.D.)

Role: primary

39+0516366252

Other Identifiers

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CE-AVEC 572/2023/Sper/IOR

Identifier Type: -

Identifier Source: org_study_id

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