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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2025
  • participants needed
    50
  • sponsor
    Istituto Ortopedico Rizzoli
Updated on 24 March 2022

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.

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.

Details
Condition Loosening, Prosthesis
Treatment Robot-assisted UKA, Standard technique UKA
Clinical Study IdentifierNCT05204797
SponsorIstituto Ortopedico Rizzoli
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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