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BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction

C

Clinical Center of Vojvodina

Status

Enrolling

Conditions

Donor Site Complication
Anterior Cruciate Ligament Rupture

Treatments

Diagnostic Test: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT06030791
MM12070106

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Group 1
Description:
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.
Treatment:
Diagnostic Test: MRI
Group 2
Description:
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.
Treatment:
Diagnostic Test: MRI

Trial contacts and locations

1

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Central trial contact

Mirko Obradovic, MD; Milan Milinkov, MD

Data sourced from clinicaltrials.gov

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