Clinical and Radiological Evaluation of ACL Reconstruction Results

NCT ID: NCT05504018

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2024-04-15

Brief 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.

Detailed 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.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

ACL reconstruction

Anterior cruciate ligament reconstruction surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Emin Okutan

Specialist in Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet Emin Okutan, MD

Role: PRINCIPAL_INVESTIGATOR

Samsun University

Locations

Ahmet E. Okutan

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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):2102-2110. doi: 10.1177/03635465221096672. Epub 2022 May 25.

Reference Type: RESULT

PMID: 35612835 (View on PubMed)

Other Identifiers

AEOACL

Identifier Type: -

Identifier Source: org_study_id