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

January 22, 2026 updated by: Stefano Zaffagnini, Istituto Ortopedico Rizzoli

Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial

The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of the study is to compare the percentage of early micromobilisation by static radiostereometric analysis (RSA) - primary outcome, gait analysis by inertial sensors to assess gait kinematics, and clinical perdormance measured by american knee society score (AKSS), oxford knee score (OKS), patient satisfaction score (PSS) and EQ5-D - secondary outcomes, among 2 groups of patients, of 25 individuals each, whi undergo medial unicompartmental knee arthroplasty.

The first group will be operated with a robot-assisted technique (with CORI Surgical System, Smith and Nephew, USA), the other with standard technique and the same implant (Journey UNI II, Smith and Nephew, USA).

The study will be a randomized and controlled blind superiority trial. Patients will not be informed about performing the surgery with one technique or the other in order to avoid potential biases in the data analysis.

Patients will be recruited at the orthoaedic and traumatologic 2nd clinica (head prof S. Zaffagnini) at IRCSS Istituto Ortopedico Rizzoli in Bologna, Italy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Unicompartmental Knee Arthrosis
  • Femoral condyles or medial tibial plate osteonecrosis
  • Healthy anterior cruciate ligament, posterior cruciate ligament and collateral ligaments of the affected knee
  • Post traumatic loss of joint configuration
  • Moderate varism deformity
  • Patients between 50 and 80 years old
  • Patients able to undergo a 2-year follow up after surgery

Exclusion Criteria:

  • Bi or Tricompartmental arthrosis
  • Unhealty anterior or posterior cruciate ligaments or collateral ligaments
  • Patients with neuromuscolar, degenerative and joint-related conditions
  • Patients younger than 50
  • Patients older than 80
  • Patients unable to undergo a 2-year follow up after surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robot-assisted UKA
Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith & Nephew, USA).
Procedure: Robot-assisted UKA
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.
Other Names:
  • CORI Surgical System, Smith and Nephew
Active Comparator: Standard technique UKA
Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique.
Procedure: Standard technique UKA
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Static radiostereometric analysis (RSA)
Time Frame: Within 7 days from surgery, during hospitalisation
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Within 7 days from surgery, during hospitalisation
Static radiostereometric analysis (RSA)
Time Frame: 3 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
3 months
Static radiostereometric analysis (RSA)
Time Frame: 6 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
6 months
Static radiostereometric analysis (RSA)
Time Frame: 12 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
12 months
Static radiostereometric analysis (RSA)
Time Frame: 24 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait analysis via inertial sensors
Time Frame: Within 7 days from surgery, during hospitalisation
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
Within 7 days from surgery, during hospitalisation
Gait analysis via inertial sensors
Time Frame: 6 months
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
6 months
Gait analysis via inertial sensors
Time Frame: 24 months
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
24 months
American Knee Society score
Time Frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Used to test knee function by the investigator: it has a clinical and a functional part
Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Oxford Knee Score
Time Frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Consists of 12 questions to be filled by the patient to assess how the prosthesis affect activities of daily living.
Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Patient Satisfaction Score
Time Frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
A short personal questionnaire that assesses subjective satisfaction after surgery
Pre-operatively, then at 3, 6, 12 and 24 months follow-up
EQ5-D questionnaire
Time Frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
a questionnaire filled by the patient assessing the overall health of the subject. It is a test used to assess quality of life index.
Pre-operatively, then at 3, 6, 12 and 24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Rizzoli

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefano Zaffagnini, Prof., IRCCS Istituto Ortopedico Rizzoli
  • Study Director: Giulio Maria Marcheggiani Muccioli, Prof., IRCCS Istituto Ortopedico Rizzoli
  • Study Chair: Stefano Fratini, Dr., IRCCS Istituto Ortopedico Rizzoli
  • Study Chair: Stefano Di Paolo, Eng., University of Bologna
  • Study Chair: Laura Bragonzoni, Dr., University of Bologna
  • Study Chair: Raffaele Zinno, Dr., University of Bologna
  • Study Chair: Giuseppe Barone, Dr., University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RSA UNI CORI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No sharing planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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