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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07377669
Acronym
MONO-LCA
Enrollment
15
Registered
2026-01-30
Start date
2025-06-01
Completion date
2026-12-31
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cruciate Ligament Rupture, Knee Arthritis Osteoarthritis

Brief summary

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

PROCEDUREUKA + ACLr

Simultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tegner-Lysholm score12 months after surgeryThe 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

MeasureTime frameDescription
SF-3612 months after surgeryIt 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.
Ucla12 months after surgeryIt 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.
Return to Sport12 months after surgeryNumber 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.
New KSS12 months after surgeryA self-administered knee function and outcome assessment test. Validation in Italian is still ongoing.
Vas12 months after surgerySubjective pain assessment scale
KT-100012 months after surgeryAn objective tool for assessing anteroposterior knee laxity
ROM12 months after surgeryActive and passive range of motion

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORStefano Zaffagnini, Full Professor

Istituto Ortopedico Rizzoli

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026