Clinical and Radiological Evaluation of ACL Reconstruction Results
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ACL reconstruction
Sponsored by
About this trial
This is an interventional screening trial for Anterior Cruciate Ligament Injuries
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.
Sites / Locations
- Ahmet E. OkutanRecruiting
Outcomes
Primary Outcome Measures
Magnetic Resonance Imaging (MRI) of Graft
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
Secondary Outcome Measures
Difference in Computed Tomography (CT) imaging of Tunnels
Femoral and Tibial Tunnel Morphological Changes
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)
Marx Activity Rating Score
Clinical Outcomes
Isokinetic Dynamometer
Measurement of knee extension and flexion torque using the isokinetic dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05504018
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction
Intervention Description
Anterior cruciate ligament reconstruction surgery
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI) of Graft
Description
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Difference in Computed Tomography (CT) imaging of Tunnels
Description
Femoral and Tibial Tunnel Morphological Changes
Time Frame
1 day, 6 months, 1 year
Title
International Knee Documentation Committee (IKDC)
Description
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)
Time Frame
1 year
Title
Marx Activity Rating Score
Description
Clinical Outcomes
Time Frame
1 year
Title
Isokinetic Dynamometer
Description
Measurement of knee extension and flexion torque using the isokinetic dynamometer
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Emin Okutan, MD
Phone
+905375757657
Email
ahmeteokutan@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Emin Okutan, MD
Organizational Affiliation
Samsun University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmet E. Okutan
City
Samsun
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet E. Okutan, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35612835
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.
Results Reference
result
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Clinical and Radiological Evaluation of ACL Reconstruction Results
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