NCT06571240

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:

  • Is the Turkish version of the Tegner Activity Score a valid scale?
  • Is the Turkish version of the Tegner Activity Score a reliable scale?
  • What is the minimal clinically important difference value of the Turkish version of the Tegner Activity Score?
  • What is the substantial clinical benefit value of the Turkish version of the Tegner Activity Score?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jan 2025Apr 2027

First Submitted

Initial submission to the registry

August 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 6, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

August 22, 2024

Last Update Submit

January 28, 2026

Conditions

Keywords

Tegner activity scoreAnterior cruciate ligament injuryValidityReliabilityPatient reported outcome

Outcome Measures

Primary Outcomes (1)

  • Functional level

    Tegner Activity Score (total score between 0-10) (higher values indicate higher functional level)

    before the surgery, after 1 week from the surgery and after 3 months from the surgery

Secondary Outcomes (2)

  • Functional level

    before the surgery

  • Functional level

    before the surgery

Study Arms (1)

Anterior Cruciate Ligament Injury Patients

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

Procedure: Anterior cruciate ligament reconstruction

Interventions

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

Anterior Cruciate Ligament Injury Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi Üniversitesi Hastanesi

Ankara, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Knee InjuriesAnterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Ozan Gür, MSc

    Kırklareli University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 26, 2024

Study Start

January 6, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations