Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07377669

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

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Knee Arthritis Osteoarthritis Cruciate Ligament Rupture

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40127, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

UKA + ACLr

Procedure

Simultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty

Primary outcomes

  1. Tegner-Lysholm score

    Time frame: 12 months after surgery

    The Tegner Lysholm Knee Scoring Scale is a questionnaire used to assess knee function and symptoms, particularly in the context of ligament injuries of the knee. It evaluates eight categories: pain, swelling, instability, locking, limp, stair climbing, squatting, and need for support. Each category is scored, and the total score, out of 100, reflects overall knee function. Higher scores indicate better knee function.

Secondary outcomes

  1. SF-36

    Time frame: 12 months after surgery

    It consists of 36 questions assessing the patient's general health, divided into eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The score ranges from a minimum of 0 to a maximum of 100 and has been validated in Italian.

  2. Ucla

    Time frame: 12 months after surgery

    It is a questionnaire used to define activity levels after knee arthroplasty. It is patient-reported and provides a score ranging from 1 to 10. It has also been validated in Italian.

  3. Return to Sport

    Time frame: 12 months after surgery

    Number of months elapsed before returning to sports activity (if resumed). Sports activities are classified according to Veil et al. into low-intensity, potentially low-intensity, intermediate-intensity, and high-intensity categories.

  4. New KSS

    Time frame: 12 months after surgery

    A self-administered knee function and outcome assessment test. Validation in Italian is still ongoing.

  5. Vas

    Time frame: 12 months after surgery

    Subjective pain assessment scale

  6. KT-1000

    Time frame: 12 months after surgery

    An objective tool for assessing anteroposterior knee laxity

  7. ROM

    Time frame: 12 months after surgery

    Active and passive range of motion

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: MONO-LCA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.