Clinical trial NCT06030791: BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction
Official title: The Impact of Bone-tendon-bone Graft Harvest and Biological Regeneration of Bone-tendon Defects on the Development of Donor Site Morbidity After Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Rupture
Donor Site Complication
Keywords: Anterior Cruciate Ligament Rupture
Autografts
Athletic Injuries
Magnetic Resonance Imaging
Lead sponsor: Clinical Center of Vojvodina
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Healing of bone-tendinous defect
timeFrame: 4 weeks postoperatively and 12 months postoperatively
measure: Change of IKDC score
timeFrame: preoperatively and 12 months postoperatively
measure: Change of Lysholm score
timeFrame: preoperatively and 12 months postoperatively
measure: Donor site morbidity score
timeFrame: 12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: University Clinical Center of Vojvodina
Study officials:
References: