Anterior Cruciate Ligament InjuriesNCT05504018
Clinical and Radiological Evaluation of ACL Reconstruction Results
A study testing ACL reconstruction in people with Anterior Cruciate Ligament Injuries, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1 years after the intervention through a clinical visit. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2022to 15 Apr 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have provided informed written written consent;
- Patients aged between 18 and 45;;
- Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
Who cannot join
- Patients who have not signed informed consent;
- Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
- Revision procedures
- Patients unable to lay still in an MRI or CT scanner
- Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiological Evaluation of Anterior Cruciate Ligament Reconstruction Surgery With Follow-up at Least 1 Year
The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1 years after the intervention through a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.
Read the detailed description
The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the outcomes remains largely debated. The study aims to analyze the potentially individual and operative parameters and identify the factors responsible for the clinical and radiological outcomes. In addition to collecting patient data in terms of features and clinical-radiological status, objective data will be documented and correlated.
The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1 years after surgery during a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- ACL reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
Anterior cruciate ligament reconstruction surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI) of Graft
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
Measured: 1 year
Secondary outcomes (4)
Difference in Computed Tomography (CT) imaging of Tunnels
Femoral and Tibial Tunnel Morphological Changes
Measured: 1 day, 6 months, 1 year
International Knee Documentation Committee (IKDC)
Patient reported outcome measures of symptoms, sports activity \& knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Measured: 1 year
Marx Activity Rating Score
Clinical Outcomes
Measured: 1 year
Isokinetic Dynamometer
Measurement of knee extension and flexion torque using the isokinetic dynamometer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start2 Sep 2022
- Primary completion4 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Emin Okutan, Samsun University
- Investigators
- Ahmet Emin Okutan, MD, Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504018
- Sponsor's protocol ID
- AEOACL
- Status last verified
- Apr 2024
- First submitted
- 15 Aug 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Putnis SE, Klasan A, Oshima T, Grasso S, Neri T, Coolican MRJ, Fritsch BA, Parker DA. Magnetic Resonance Imaging Assessment of Hamstring Graft Healing and Integration 1 and Minimum 2 Years after ACL Reconstruction. Am J Sports Med. 2022 Jul;50(8):2102-2110. doi: 10.1177/03635465221096672. Epub 2022 May 25.
PubMed 35612835
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation of Anterior Cruciate Ligament Reconstruction Surgery With Follow-up at Least 1 Year
- ClinicalTrials.gov ID
- NCT05504018
- Acronym / sponsor ID
- AEOACL
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 17 Aug 2022 (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 study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1 years after the intervention through a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.
Detailed description
The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the outcomes remains largely debated. The study aims to analyze the potentially individual and operative parameters and identify the factors responsible for the clinical and radiological outcomes. In addition to collecting patient data in terms of features and clinical-radiological status, objective data will be documented and correlated.
The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1 years after surgery during a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who have provided informed written written consent;
- Patients aged between 18 and 45;;
- Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
Key exclusion criteria (5 listed)
- Patients who have not signed informed consent;
- Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
- Revision procedures
- Patients unable to lay still in an MRI or CT scanner
- Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
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 |
|---|---|---|
| ACL reconstructionAnterior cruciate ligament reconstruction surgery | Procedure or surgery | – |
Primary outcome
Magnetic Resonance Imaging (MRI) of Graft
Time frame: 1 year
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
4 secondary outcomes
Difference in Computed Tomography (CT) imaging of Tunnels
Time frame: 1 day, 6 months, 1 year
International Knee Documentation Committee (IKDC)
Time frame: 1 year
Marx Activity Rating Score
Time frame: 1 year
Isokinetic Dynamometer
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 35612835Putnis SE, Klasan A, Oshima T, Grasso S, Neri T, Coolican MRJ, Fritsch BA, Parker DA. Magnetic Resonance Imaging Assessment of Hamstring Graft Healing and Integration 1 and Minimum 2 Years after ACL Reconstruction. Am J Sports Med. 2022 Jul;50(8):2102-2110. doi: 10.1177/03635465221096672. Epub 2022 May 25.
- Individual participant dataSharing planned: No
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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.
Ahmet Emin Okutan, MD principal investigator
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction in people with Anterior Cruciate Ligament Injuries, run by Samsun University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Apr 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI) of Graft (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504018, which also lists 1 linked publication.
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 16 Apr 2024.