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

NCT05204797 | Active Not Recruiting

• 1 other identifier: RSA UNI CORI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

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 UKA PROCEDURE

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 UKA PROCEDURE

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

Standard technique UKA

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological 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

• Laura Bragonzoni, Dr.

  University of Bologna

  STUDY CHAIR

• Raffaele Zinno, Dr.

  University of Bologna

  STUDY CHAIR

• Giuseppe Barone, Dr.

  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

Model Details: Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: January 24, 2022
• Study Start: October 7, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)