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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cruciate Ligament Rupture; Knee Arthritis Osteoarthritis
• Intervention / Treatment: Procedure: UKA + ACLr

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

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40127
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by monocompartimental knee arthosis and ACL complete lesion in the same knee who underwent simoultaneous one stage ACLr + UKA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UKA + LCA patients; Patients who underwent simultaneous anterior cruciate ligament and monocompartimental knee replacement	Procedure: UKA + ACLr; Simultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tegner-Lysholm score	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.	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	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.	12 months after surgery
Ucla	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.	12 months after surgery
Return to Sport	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.	12 months after surgery
New KSS	A self-administered knee function and outcome assessment test. Validation in Italian is still ongoing.	12 months after surgery
Vas	Subjective pain assessment scale	12 months after surgery
KT-1000	An objective tool for assessing anteroposterior knee laxity	12 months after surgery
ROM	Active and passive range of motion	12 months after surgery

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Stefano Zaffagnini, Full Professor, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MONO-LCA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes