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Clinical Trials in Italy / NCT05204797
Active, not recruiting Not applicable

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

NCT05204797 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2021-10-07
Last updated
2026-01-23

Condition(s) studied

Loosening, Prosthesis

Investigational drug(s) / intervention(s)

Robot-assisted UKAStandard technique UKA

Robot-assisted UKA: Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.

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

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
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

Primary outcome measure(s)

  • Static radiostereometric analysis (RSA) — Within 7 days from surgery, during hospitalisation
    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
  • Static radiostereometric analysis (RSA) — 3 months
    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
  • Static radiostereometric analysis (RSA) — 6 months
    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
  • Static radiostereometric analysis (RSA) — 12 months
    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
  • Static radiostereometric analysis (RSA) — 24 months
    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

Trial sites (1)

FacilityCityRegionStatus
IRCCS Istituto Ortopedico Rizzoli Bologna Emilia-Romagna

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05204797 on ClinicalTrials.gov ↗ ← All trials in Italy