Establishing the Clinical Significance Values of the Lysholm Knee Score

January 28, 2026 updated by: Ozan Gür, PT, Kırklareli University

Establishing the Clinical Significance Values of the Lysholm Knee Score in Patients Undergoing Anterior Cruciate Ligament Reconstruction

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06490
        • Recruiting
        • Gazi Universitesi Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted with people undergoing anterior cruciate ligament reconstruction at Gazi University Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anterior Cruciate Ligament Reconstruction Patients
Patients who will undergo anterior cruciate ligament reconstruction because of anterior cruciate ligament rupture
Procedure: Anterior cruciate ligament reconstruction
Patients with anterior cruciate ligament rupture will undergo anterior cruciate ligament reconstruction surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional level
Time Frame: before the surgery and after 3 months from the surgery
Lysholm Knee Score (total score between 0-100) (higher values indicate higher functional level)
before the surgery and after 3 months from the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırklareli University

Collaborators

Gazi University

Investigators

  • Principal Investigator: Ozan Gür, MSc, Kırklareli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024 - 1202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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