- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06571227
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
- Name: Ozan Gür, MSc
- Phone Number: +90 506 338 38 49
- Email: ozan.gur94@gmail.com
Study Locations
-
-
-
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
|
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
Collaborators
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.