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

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: Recruiting
• Conditions: Loosening, Prosthesis
• Intervention / Treatment: Procedure: Robot-assisted UKA; Procedure: Standard technique UKA

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Zaffagnini, Prof.; Phone Number: 00390516366111; Email: stefano.zaffagnini@unibo.it

Study Locations

• Italy
  • Emilia Romagna
    • Bologna, Emilia Romagna, Italy, 40136
      • Recruiting
      • IRCCS Istituto Ortopedico Rizzoli
      • Contact: Stefano Zaffagnini, Prof.; Phone Number: 00390516366111; Email: stefano.zaffagnini@unibo.it
      • Principal Investigator: Stefano Zaffagnini, Prof.
      • Sub-Investigator: Giulio Maria Marcheggiani Muccioli, Prof.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analysis via inertial sensors	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	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	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	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	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	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	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

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: January 8, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID 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