Establishing the Clinical Significance Values of the Lysholm Knee Score

Recruiting

• Conditions: Knee Injuries
• Interventions: Procedure: Anterior cruciate ligament reconstruction

• Registration Number: NCT06571227
• Lead Sponsor: Kırklareli University

Brief Summary

The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:

* What is the minimal clinically important difference value of the Lysholm Knee Score?

* What is the substantial clinical benefit value of the Lysholm Knee Score?

* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the minimal clinically important difference value?

* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the substantial clinical benefit value?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Study Start: 2025-01-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• to be over 18 years old
• to undergo surgery for a ruptured anterior cruciate ligament

Exclusion Criteria

• to have metabolic or autoimmune diseases
• to undergo revision anterior cruciate ligament surgery or anterior cruciate ligament repair
• to have cognitive issues that will hinder the completion of the study forms
• to lack sufficient proficiency in Turkish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior Cruciate Ligament Reconstruction Patients	Anterior cruciate ligament reconstruction	Patients who will undergo anterior cruciate ligament reconstruction because of anterior cruciate ligament rupture

Primary Outcome Measures

Name	Time	Method
Functional level	before the surgery and after 3 months from the surgery	Lysholm Knee Score (total score between 0-100) (higher values indicate higher functional level)

Trial Locations

Locations (1)

Gazi Üniversitesi Hastanesi; 🇹🇷 Ankara, Turkey