Anterior Cruciate Ligament RuptureNCT06030791
BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction
An observational study of Anterior Cruciate Ligament Rupture and Donor Site Complication, run by Clinical Center of Vojvodina at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Donor Site Complication
- What is being tested?
- MRI
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- 31 Oct 2022to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Multiligament knee injuries
- Both knees injuries
- ACL re-rupture
- Postoperative complications in the form of infection
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center of Vojvodina
Novi Sad, 21000
Mirko Obradovic, MD, +381643653086, mirko127@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- MRI
- Keywords
- Anterior Cruciate Ligament Rupture, Autografts, Athletic Injuries, Magnetic Resonance Imaging
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI of operated knee
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start31 Oct 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Center of Vojvodina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirko Obradovic, Clinical Center of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030791
- Sponsor's protocol ID
- MM12070106
- Status last verified
- Sep 2023
- First submitted
- 3 Sep 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06030791
- Acronym / sponsor ID
- MM12070106
- Keywords
- Anterior Cruciate Ligament Rupture, Autografts, Athletic Injuries, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinical Center of VojvodinaUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: MRIAll 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. |
| Group 2 | – | Diagnostic Test: MRIAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Multiligament knee injuries
- Both knees injuries
- ACL re-rupture
- Postoperative complications in the form of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI of operated knee | Diagnostic test | Group 1, Group 2 |
Primary outcome
Healing of bone-tendinous defect
Time frame: 4 weeks postoperatively and 12 months postoperatively
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.
Change of IKDC score
Time frame: preoperatively and 12 months postoperatively
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.
Change of Lysholm score
Time frame: preoperatively and 12 months postoperatively
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.
Donor site morbidity score
Time frame: 12 months postoperatively
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture and Donor Site Complication, run by Clinical Center of Vojvodina at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirko Obradovic, MD (+381643653086, mirko127@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of bone-tendinous defect (time frame: 4 weeks postoperatively and 12 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.