BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction

NCT06030791 | Unknown

• 1 other identifier: MM12070106
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Rupture; Donor Site Complication

Keywords

Anterior Cruciate Ligament Rupture; Autografts; Athletic Injuries; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group 1

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

Group 2

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

Interventions

MRI DIAGNOSTIC_TEST

MRI of operated knee

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Multiligament knee injuries
• Both knees injuries
• ACL re-rupture
• Postoperative complications in the form of infection

Sponsors & Collaborators

• Clinical Center of Vojvodina: lead

Study Sites (1)

University Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Athletic Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Mirko Obradovic, MD

CONTACT

+381643653086; mirko127@gmail.com

Milan Milinkov, MD

CONTACT

+381629784768; milinkovmilan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: October 31, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

SE (1)