Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System

NCT ID: NCT05365022

Last Updated: 2022-05-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2022-09-30

Brief Summary

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Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.

Detailed Description

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Conditions

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Knee Prosthetic Surgery Robotic Assistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Non-Robotic Assisted Knee Prosthetic Surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

ROSA® System Robotic Assisted Knee Prosthetic Surgery

Group Type ACTIVE_COMPARATOR

ROSA® System Robotic Assisted Knee Prosthetic Surgery

Intervention Type DEVICE

Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System

Interventions

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ROSA® System Robotic Assisted Knee Prosthetic Surgery

Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Knee osteoarthritis requiring PS Knee Prosthesis

* Requiring Constrained Prosthesis
* Metal Allergy
* Neurological disorders.
* Cognitive impairment
* Not giving consent.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Borja Alcobía-Díaz MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Borja Alcobía-Díaz MD, PhD

MD, PhD. Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Borja Alcobia-Díaz, MD, PhD

Role: STUDY_CHAIR

Clinical Assistant

Locations

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Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Borja Alcobia-Díaz, MD, PhD

Role: CONTACT

913303001 ext. 3638

Facility Contacts

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Borja Alcobia-Díaz, MD, PhD

Role: primary

913303001 ext. 3638

Other Identifiers

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22/081-EC_P

Identifier Type: -

Identifier Source: org_study_id

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