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RecruitingNCT06571227Updated Jan 30, 2026

Establishing the Clinical Significance Values of the Lysholm Knee Score

An observational study in Knee Injuries, sponsored by Kırklareli University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Kırklareli University · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
69
Ages
18 Years and older
Sex
All
01

Study 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?
02

Conditions studied

  • Knee Injuries

Keywords

  • Lsholm knee score
  • Anterior cruciate ligament injury
  • Minimal important change
  • Substantial clinical benefit
  • Clinical significance
  • Patient reported outcome
03

In context

Knee Injuries

267 studies on the registry are indexed under Knee Injuries; 59 are open to participants now.

This study's planned enrollment of 69 is below the median of 82 across 79 observational studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

Kırklareli University is the lead sponsor of 49 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • to have metabolic or 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
69 participants (estimated)
Patient registry
No

Groups and cohorts

  • Anterior Cruciate Ligament Reconstruction Patients

    Patients who will undergo anterior cruciate ligament reconstruction because of anterior cruciate ligament rupture

    Procedure: Anterior cruciate ligament reconstruction

Interventions

  • ProcedureAnterior cruciate ligament reconstruction

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

06

What researchers measure

Primary outcomes

  1. Functional level

    Lysholm Knee Score (total score between 0-100) (higher values indicate higher functional level)

    Time frame: before the surgery and after 3 months from the surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Apr 2027, 27 months after the start.

Of 30 observational studies under Knee Injuries, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 27 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2024
First posted
Aug 26, 2024
StartActual
Jan 6, 2025
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Jan 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06571227
Lead sponsor
Kırklareli University
Collaborators
Gazi University
Responsible party
Ozan Gür, PT (Research Assistant, Kırklareli University) — Principal investigator
First posted
Aug 26, 2024
Start date
Jan 6, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jan 30, 2026

Study contacts

Ozan Gür, MSc
Contact
ozan.gur94@gmail.com
+90 506 338 38 49
Ozan Gür, MSc
principal investigator · Kırklareli University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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