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

NCT07377669 | Enrolling By Invitation DMC FDA Drug FDA Device

• 1 other identifier: MONO-LCA
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Arthritis Osteoarthritis; Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• SF-36

  12 months after surgery

• Ucla

  12 months after surgery

• Return to Sport

  12 months after surgery

• New KSS

  12 months after surgery

• Vas

  12 months after surgery

Study Arms (1)

UKA + LCA patients

Patients who underwent simultaneous anterior cruciate ligament and monocompartimental knee replacement

Procedure: UKA + ACLr

Interventions

UKA + ACLr PROCEDURE

Simultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty

UKA + LCA patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40127, Italy

Location

Study Officials

• Stefano Zaffagnini, Full Professor

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 30, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

IT (1)