BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction

NCT ID: NCT06030791

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-10-31

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.

Conditions

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Anterior Cruciate Ligament Rupture Donor Site Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI

Intervention Type DIAGNOSTIC_TEST

MRI of operated knee

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.

MRI

Intervention Type DIAGNOSTIC_TEST

MRI of operated knee

Interventions

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MRI

MRI of operated knee

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Center of Vojvodina

OTHER

Sponsor Role lead

Responsible Party

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Mirko Obradovic

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Clinical Center of Vojvodina

Novi Sad, , Serbia

Site Status RECRUITING

Countries

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Serbia

Central Contacts

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Mirko Obradovic, MD

Role: CONTACT

+381643653086

Milan Milinkov, MD

Role: CONTACT

+381629784768

Facility Contacts

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Mirko Obradovic, MD

Role: primary

+381643653086

Other Identifiers

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MM12070106

Identifier Type: -

Identifier Source: org_study_id

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