BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction

Study Overview
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Brief Summary
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The aim of this observational study is to examine the connection between bone-tendinous defects after BTB graft harvest and the development of anterior knee pain.

Detailed Description
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The purpose of this study is to investigate the impact of bone-tendinous defects after ACL reconstruction on the development of anterior knee pain. We will assess the presence and extent of bone-tendinous defects using MRI scans, which will be conducted at two time points: 4 weeks and 1 year after ACL reconstruction surgery. Furthermore, we will compare the healing progress of the bone-tendinous defects observed on the MRI scans. In addition, we will evaluate the correlation between the residual bone-tendinous defect and knee functionality by comparing the results with knee functional test (IKDC form, Lysholm score, Donor site morbidity score). All individuals participating in the study have provided their informed consent by signing the necessary documents prior to their inclusion in the research.

Official Title
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The Impact of Bone-tendon-bone Graft Harvest and Biological Regeneration of Bone-tendon Defects on the Development of Donor Site Morbidity After Anterior Cruciate Ligament Reconstruction

Conditions
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Anterior Cruciate Ligament Rupture, Donor Site Complication

Intervention / Treatment
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* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients Diagnosed with ACL rupture based on medical history and clinical examination Confirmed ACL rupture on MRI scans A sufficient level of education to understand study procedures and be able to communicate with site personnel Exclusion Criteria: Multiligament knee injuries Both knees injuries ACL re-rupture Postoperative complications in the form of infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>All examinees will undergo ACL reconstruction using BTB graft. MRI scans of operated knee will be conducted at two time points: 4 weeks and 1 year after ACL reconstruction surgery. | Diagnostic Test: MRI<br>* MRI of operated knee<br>|
| Group 2<br>All examinees will undergo ACL reconstruction using BTB graft. MRI scans of operated knee will be conducted at two time points: 4 weeks and 1 year after ACL reconstruction surgery. | Diagnostic Test: MRI<br>* MRI of operated knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of bone-tendinous defect | The healing progress will be assessed through MRI scans conducted at two time points: 4 weeks and 1 year after the surgical intervention. The measurement of bone-tendinous defect healing will be expressed both in cubic millimeters and as a percentage. The cubic millimeter measurement will quantify the size of the defect observed on the MRI scans. This measurement provides a precise assessment of the volume of the defect, allowing for accurate tracking of the healing process over time. In addition, the healing progress will also be expressed as a percentage, comparing the size of the defect at each time point relative to the initial defect size observed at the 4-week scan. This percentage calculation will offer a relative measure of the extent to which the bone-tendinous defect has healed or progressed over the course of the study. | 4 weeks postoperatively and 12 months postoperatively | 
| Change of IKDC score | The International Knee Documentation Committee (IKDC) form is a validated patient-reported outcome measure used to assess knee function and symptoms. It is a self-administered questionnaire that helps evaluate the subjective knee-related outcomes and overall knee function of individuals. The IKDC form covers various aspects, including symptoms, daily activities, sports and recreational activities, and knee-related quality of life. It consists of items that assess pain, stability, swelling, locking, giving way, range of motion, and the ability to perform specific tasks. Possible IKDC form score range from 0 to 100 and scores are divided into categories and interpreted based on cutoff values. Scores above 90 or 95 may be considered excellent or near-normal, scores between 80 and 89 may be considered good or satisfactory, scores between 70 and 79 may be considered fair or moderate, and scores below 70 may be considered poor or unsatisfactory. | preoperatively and 12 months postoperatively | 
| Change of Lysholm score | The Lysholm Knee Scoring Scale, often simply referred to as the Lysholm Score, is a patient-reported outcome measure used to evaluate the symptoms and functional limitations in individuals with knee injuries, especially those related to anterior cruciate ligament (ACL) damage. The Lysholm Score is commonly utilized in clinical practice and research to monitor the outcomes of knee surgeries or interventions. Categories Evaluated by Lysholm Knee Scoring Scale are: limping, using support, pain, locking, swelling, stair climbing, squatting and instability. The total score can range from 0 (severe symptoms and limitations) to 100 (no symptoms or limitations), with scores interpreted as Excellent, Good, Fair, or Poor based on the range they fall into. | preoperatively and 12 months postoperatively | 
| Donor site morbidity score | Donor site morbidity score is a new 10-question patient-oriented instrument that was developed to adequately assess morbidity at the site of BTB harvest. The intent was to measure subjective outcomes, including donor site pain, numbness, function, strength, and physical appearance at the surgical site. All questions had 4 possible answers, each representing increasing symptom severity and patient dissatisfaction. Answer choices were assigned 0 to 10 points depending on the severity or functional restriction. A perfect score of 100 represented no complaints whatsoever. Total scores were subdivided into 4 categories representing overall morbidity after surgery: excellent (≥93.3 points), good (80.0-93.2 points), fair (50.0-79.9 points), and poor (≤49.9 points). | 12 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament Rupture, Autografts, Athletic Injuries, Magnetic Resonance Imaging