Clinical and Radiological Evaluation of ACL Reconstruction Results

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Clinical and Radiological Evaluation of Anterior Cruciate Ligament Reconstruction Surgery With Follow-up at Least 1 Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504018
• Other study ID #: AEOACL
• Status: Completed
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Samsun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1 years after the intervention through a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.

Description:

The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the outcomes remains largely debated. The study aims to analyze the potentially individual and operative parameters and identify the factors responsible for the clinical and radiological outcomes. In addition to collecting patient data in terms of features and clinical-radiological status, objective data will be documented and correlated.

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1 years after surgery during a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients who have provided informed written written consent;

• Patients aged between 18 and 45;;

• Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)

Exclusion Criteria:

• Patients who have not signed informed consent;

• Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery

• Revision procedures

• Patients unable to lay still in an MRI or CT scanner

• Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• ACL reconstruction
Anterior cruciate ligament reconstruction surgery

Locations

Country	Name	City	State
Turkey	Ahmet E. Okutan	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Putnis SE, Klasan A, Oshima T, Grasso S, Neri T, Coolican MRJ, Fritsch BA, Parker DA. Magnetic Resonance Imaging Assessment of Hamstring Graft Healing and Integration 1 and Minimum 2 Years after ACL Reconstruction. Am J Sports Med. 2022 Jul;50(8):2102-211 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging (MRI) of Graft	Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation	1 year
Secondary	Difference in Computed Tomography (CT) imaging of Tunnels	Femoral and Tibial Tunnel Morphological Changes	1 day, 6 months, 1 year
Secondary	International Knee Documentation Committee (IKDC)	Patient reported outcome measures of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)	1 year
Secondary	Marx Activity Rating Score	Clinical Outcomes	1 year
Secondary	Isokinetic Dynamometer	Measurement of knee extension and flexion torque using the isokinetic dynamometer	1 year