An observational study in Anterior Cruciate Ligament Rupture and Donor Site Complication, sponsored by Clinical Center of Vojvodina. Recruiting at 1 site in Serbia. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Clinical Center of Vojvodina · Observational
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.
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.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 60 is below the median of 98 across 153 observational studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Clinical Center of Vojvodina is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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The study population will consist of individuals who have undergone ACL reconstruction surgery due to ligament injury. Participants will be recruited from the orthopedic clinic at University Clinical Center of Vojvodina. The inclusion criteria for this study are individuals aged 18 to 45 years old. Participants' medical records, including preoperative evaluations and surgical reports, will be reviewed to confirm eligibility and collect relevant baseline data.
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Exclusion Criteria:
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
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
MRI of operated knee
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 12 months postoperatively
Started Oct 2022 (actual). Primary completion is estimated for Oct 2024, 24 months after the start.
Of 73 non-industry observational studies under Anterior Cruciate Ligament Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 167. This study's planned 24 months is below that.
Counting every sponsor, half of 82 studies reached it within 37 months; a quarter within 13 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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Clinical Center of Vojvodina