Clinical trial NCT05504018: Clinical and Radiological Evaluation of ACL Reconstruction Results
Official title: Clinical and Radiological Evaluation of Anterior Cruciate Ligament Reconstruction Surgery With Follow-up at Least 1 Year
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI) of Graft
timeFrame: 1 year
Secondary outcomes:
measure: Difference in Computed Tomography (CT) imaging of Tunnels
timeFrame: 1 day, 6 months, 1 year
measure: International Knee Documentation Committee (IKDC)
timeFrame: 1 year
measure: Marx Activity Rating Score
timeFrame: 1 year
measure: Isokinetic Dynamometer
timeFrame: 1 year
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ahmet E. Okutan
Study officials:
affiliation: Samsun University
name: Ahmet Emin Okutan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.