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Enrolling by invitation NCT07377669

A Retrospective and Prospective Study: Monocompartimental Knee Arthroplasty Combined With Anterior Cruciate Ligament Reconstruction Surgery - a Pilot Study

Observational Knee Arthritis Osteoarthritis Cruciate Ligament Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UKA + ACLr.
Who it may be relevant to
Registry conditions: Knee Arthritis Osteoarthritis, Cruciate Ligament Rupture. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to collect datas about patient who underwent simultaneous monocompartimental knee replacement and anterior cruciate ligament recontruction

Detailed description

The aim is to understand if anterior cruciate ligament recontruction is mandatory in case of monocompartimental knee replacement, given the fact that anterior stability could be compromised at first in ACL (anterior cruciate ligament) deficient knees. Current datas in literature are not sufficient to establish if ACL must always be recontructed or if only in some cases

Interventions

  • Procedure UKA + ACLr
    Simultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty

Primary outcome measures

  • Tegner-Lysholm score [Time frame: 12 months after surgery]
Secondary outcome measures (7)
  • SF-36 [Time frame: 12 months after surgery]
  • Ucla [Time frame: 12 months after surgery]
  • Return to Sport [Time frame: 12 months after surgery]
  • New KSS [Time frame: 12 months after surgery]
  • Vas [Time frame: 12 months after surgery]
  • KT-1000 [Time frame: 12 months after surgery]
  • ROM [Time frame: 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • monocompartimental knee arthrosis and ACL complete lesion
  • High functional request
  • Follow up >12 m
  • Complete clinical and radiographic documentation
  • Patients who accepted to partecipate to the study
  • Patients who did non underwent surgical procedures in the controlateral knee

Exclusion criteria

  • two stage surgeries (UKA and ACLr)
  • patients affected by neuromuscolar disorders, or psychomotor disorders
  • further knee ligamentous associated lesions
  • revision surgery
  • low functional request due to comorbilities

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Istituto Ortopedico Rizzoli — Bologna

Identifiers

NCT: NCT07377669 · MONO-LCA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗