UnknownNot Applicable

BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction

Serbia60 participantsStarted 2022-10-31

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Healing of bone-tendinous defect

Timeframe: 4 weeks postoperatively and 12 months postoperatively

Change of IKDC score

Timeframe: preoperatively and 12 months postoperatively

Change of Lysholm score

Timeframe: preoperatively and 12 months postoperatively

Donor site morbidity score

Timeframe: 12 months postoperatively

Trial details

NCT IDNCT06030791

SponsorClinical Center of Vojvodina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-31

Contact for this trial

Mirko Obradovic, MD

+381643653086 mirko127@gmail.com

View on ClinicalTrials.gov More Anterior Cruciate Ligament Rupture trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Healing of bone-tendinous defect

Timeframe: 4 weeks postoperatively and 12 months postoperatively

Change of IKDC score

Timeframe: preoperatively and 12 months postoperatively

Change of Lysholm score

Timeframe: preoperatively and 12 months postoperatively

Donor site morbidity score

Timeframe: 12 months postoperatively