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NCT Number: NCT05204797

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

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted UKA

Procedure

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

Standard technique UKA

Procedure

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

Primary outcomes

  1. 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

  2. Static radiostereometric analysis (RSA)

    Time frame: 3 months

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

  3. Static radiostereometric analysis (RSA)

    Time frame: 6 months

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

  4. Static radiostereometric analysis (RSA)

    Time frame: 12 months

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

  5. Static radiostereometric analysis (RSA)

    Time frame: 24 months

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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