Trials Sponsors Conditions Drugs Pricing

Conditions

Loosening, Prosthesis

Outcome Measures

Primary Outcomes (5)

Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Within 7 days from surgery, during hospitalisation
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
3 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
6 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
12 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
24 months

Secondary Outcomes (7)

Gait analysis via inertial sensors
Within 7 days from surgery, during hospitalisation
Gait analysis via inertial sensors
6 months
Gait analysis via inertial sensors
24 months
American Knee Society score
Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Oxford Knee Score
Pre-operatively, then at 3, 6, 12 and 24 months follow-up
+2 more secondary outcomes

Study Arms (2)

Robot-assisted UKA

EXPERIMENTAL

Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith \& Nephew, USA).

Procedure: Robot-assisted UKA

Standard technique UKA

ACTIVE COMPARATOR

Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique.

Procedure: Standard technique UKA

Interventions

Robot-assisted UKAProcedure

Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.

Also known as: CORI Surgical System, Smith and Nephew

Robot-assisted UKA

Standard technique UKAProcedure

Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.

Eligibility Criteria

Age50 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Unicompartmental Knee Arthrosis
Femoral condyles or medial tibial plate osteonecrosis

Sponsors & Collaborators

Istituto Ortopedico Rizzoli
Otherlead
Smith & Nephew, Inc.
Industrycollaborator

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Stefano Zaffagnini, Prof.
IRCCS Istituto Ortopedico Rizzoli
PRINCIPAL INVESTIGATOR
Giulio Maria Marcheggiani Muccioli, Prof.
IRCCS Istituto Ortopedico Rizzoli
STUDY DIRECTOR
Stefano Fratini, Dr.
IRCCS Istituto Ortopedico Rizzoli
STUDY CHAIR
Stefano Di Paolo, Eng.
University of Bologna
STUDY CHAIR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: At the research office of health professions at IRCCS Istituto Ortopedico Rizzoli in Bologna, Italy (coordinating centre), a block of 5 randomisation list using the site "www.randomisation.com" will be generated. A sequence of opaque envelopes will be set up with a sequential number on the outside. A label will be placed iside the envelope that will contain the words "CORI" or "STANDARD", according to the sequence indicated by the generated list. Envelopes will be always sealed at the Research Centre and the list kept under lock. The envelopes will be placed in a dedicated box and delivered to the studio manager.
Purpose: SCREENING
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of Orthopaedics and Traumatology II Clinic

Study Record Dates

First Submitted

September 27, 2021

First Posted

January 24, 2022

Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After UKA

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (7)

Study Arms (2)

Robot-assisted UKA

Standard technique UKA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (7)

Study Arms (2)

Robot-assisted UKA

Standard technique UKA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations