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Establishing the Clinical Significance Values of the Lysholm Knee Score

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06571227
Enrollment
69
Registered
2024-08-26
Start date
2025-01-06
Completion date
2027-04-01
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries

Keywords

Lsholm knee score, Anterior cruciate ligament injury, Minimal important change, Substantial clinical benefit, Clinical significance, Patient reported outcome

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?

Interventions

PROCEDUREAnterior cruciate ligament reconstruction

Patients with anterior cruciate ligament rupture will undergo anterior cruciate ligament reconstruction surgery.

Sponsors

Kırklareli University
Lead SponsorOTHER
Gazi University
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional levelbefore the surgery and after 3 months from the surgeryLysholm Knee Score (total score between 0-100) (higher values indicate higher functional level)

Countries

Turkey (Türkiye)

Contacts

CONTACTOzan Gür, MSc
ozan.gur94@gmail.com+90 506 338 38 49
PRINCIPAL_INVESTIGATOROzan Gür, MSc

Kırklareli University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026