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

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Recruiting
CT.gov ID
NCT05204797
Collaborator
Smith & Nephew, Inc. (Industry)
50
Enrollment
1
Location
2
Arms
39.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Robot-assisted UKA
  • Procedure: Standard technique UKA
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).
Masking:
Single (Participant)
Masking Description:
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.
Primary Purpose:
Screening
Official Title:
Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial
Actual Study Start Date :
Oct 7, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

    Outcome Measures

    Primary Outcome Measures

    1. Static radiostereometric analysis (RSA) [Within 7 days from surgery, during hospitalisation]

      Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    2. Static radiostereometric analysis (RSA) [3 months]

      Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    3. Static radiostereometric analysis (RSA) [6 months]

      Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    4. Static radiostereometric analysis (RSA) [12 months]

      Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    5. Static radiostereometric analysis (RSA) [24 months]

      Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    Secondary Outcome Measures

    1. Gait analysis via inertial sensors [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.

    2. Gait analysis via inertial sensors [6 months]

      Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.

    3. Gait analysis via inertial sensors [24 months]

      Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.

    4. American Knee Society score [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

    5. Oxford Knee Score [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.

    6. Patient Satisfaction Score [Pre-operatively, then at 3, 6, 12 and 24 months follow-up]

      A short personal questionnaire that assesses subjective satisfaction after surgery

    7. EQ5-D questionnaire [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Istituto Ortopedico Rizzoli Bologna Emilia Romagna Italy 40136

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli
    • Smith & Nephew, Inc.

    Investigators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefano Zaffagnini, Head of Orthopaedics and Traumatology II Clinic, Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT05204797
    Other Study ID Numbers:
    • RSA UNI CORI
    First Posted:
    Jan 24, 2022
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Prosthesis Failure

    Study Results

    No Results Posted as of Jan 24, 2022