Clinical and Radiological Evaluation of ACL Reconstruction Results
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 17, 2022
CompletedStudy Start
First participant enrolled
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedApril 16, 2024
April 1, 2024
1.6 years
August 15, 2022
April 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Magnetic Resonance Imaging (MRI) of Graft
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
1 year
Secondary Outcomes (4)
Difference in Computed Tomography (CT) imaging of Tunnels
1 day, 6 months, 1 year
International Knee Documentation Committee (IKDC)
1 year
Marx Activity Rating Score
1 year
Isokinetic Dynamometer
1 year
Interventions
Anterior cruciate ligament reconstruction surgery
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmet E. Okutan
Samsun, Turkey (Türkiye)
Related 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):2102-2110. doi: 10.1177/03635465221096672. Epub 2022 May 25.
PMID: 35612835RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmet Emin Okutan, MD
Samsun University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in Orthopaedics
Study Record Dates
First Submitted
August 15, 2022
First Posted
August 17, 2022
Study Start
September 2, 2022
Primary Completion
April 4, 2024
Study Completion
April 15, 2024
Last Updated
April 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share