ACL InjuriesNCT05180123
Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
A study testing Anterior cruciate ligament reconstruction in people with ACL Injuries and Knee Instability, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
Trial summary
In this retrospective research results of ACL reconstruction in adolescent will be evaluated. As we know ACL ruptures become more frequent and more often operated these days. According to literature the results in patients younger than 20 years old are worse. Therefore clinical and MRI evaluation will be performed. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- ACL Injuries, Knee Instability
- What is being tested?
- Anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2021to 30 Dec 2025
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 10-17 years at time of surgery
- ACL full thickness lesion
- meniscal lesions repaired simultaneously
- completed research protocol
Who cannot join
- age <10 yo and >17 yo.
- PCL concomitant injury
- polytrauma
- other same knee surgeries performed before intervention
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Polish Mother Memorial Hospital Research Institute
Lodz, 93-338
Krzysztof Małecki, Ph.D., +48 692043139, krzynormal@wp.pl
About this study
In this retrospective research results of ACL reconstruction in adolescent will be evaluated. As we know ACL ruptures become more frequent and more often operated these days. According to literature the results in patients younger than 20 years old are worse. Therefore clinical and MRI evaluation will be performed. The aim of the study is to assess subjective and objective functional outcome of ACL reconstruction with follow-up at least 3 years. MRI scans will be evaluated to highlight any early signs of osteoarthritis and describe graft morphology. IKDC, KOOS scales will be utilised for subjective evaluation. Clinical tests such as Lachman's, pivot shift, Appley's along with anterior tibial shift measurement with digital arthrometer for objective assessment will be also performed. Additionally isokinetic tests will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured .
Preliminary group of patients consists of 150 cases with follow-up at least 3 years, operated in age 12-17 years. All cases available for the study will be assessed with methodology above. Dedicated statistical test will be utilised to evaluate the results.
- Conditions
- ACL Injuries, Knee Instability
- Being tested
- Anterior cruciate ligament reconstruction
- Keywords
- Anterior cruciate ligament, ACL, Knee injuries, Adolescents, ACL injuries
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cruciate ligament reconstructionProcedure or surgery
Adolescent patients with confirmed full thickness ACL injury were operated arthroscopically with semitendinosus and gracilis autograft anatomical reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Patients after ACL reconstruction in adolescence | Other | Not described Receives: Procedure: Anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lachman test
Assessment of knee stability in sagittal plane (positive/negative)
Measured: up to six months
Pivot shift test
Assessment of knee rotational stability (positive/negative)
Measured: up to six months
Apley's distraction test
Assessment of knee rotational stability (positive/negative)
Measured: up to six months
MRI evaluation
Assessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) [cm3]
Measured: up to 12 months
Isokinetic evaluation - peak torque
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of peak torque (Newton-meter, [Nm])
Measured: up to 12 months
Arthrometer testing
Assessment of knee stability in sagittal plane with digital arthrometer use (millimeters, [mm])
Measured: up to six months
Isokinetic evaluation - torque at 30 deg
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of torque at 30 deg (Newton-meter, [Nm])
Measured: up to 12 months
Isokinetic evaluation - angle of peak torque
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of angle of peak torque (degrees [deg]))
Measured: up to 12 months
Isokinetic evaluation - time to peak torque
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of time to peak torque (milliseconds [ms])
Measured: up to 12 months
Isokinetic evaluation - work fatigue
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of work fatigue (percent [%])
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Dec 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof Małecki, Ph.D., Study director, Polish Mother Memorial Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180123
- Sponsor's protocol ID
- PMMHRI-BCO.37/2019-A
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request via e-mail krzynormal@wp.pl
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
- ClinicalTrials.gov ID
- NCT05180123
- Acronym / sponsor ID
- PMMHRI-BCO.37/2019-A
- Conditions
- ACL Injuries, Knee Instability
- Keywords
- Anterior cruciate ligament, ACL, Knee injuries, Adolescents, ACL injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Jan 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.
In this retrospective research results of ACL reconstruction in adolescent will be evaluated. As we know ACL ruptures become more frequent and more often operated these days. According to literature the results in patients younger than 20 years old are worse. Therefore clinical and MRI evaluation will be performed. The aim of the study is to assess subjective and objective functional outcome of ACL reconstruction with follow-up at least 3 years. MRI scans will be evaluated to highlight any early signs of osteoarthritis and describe graft morphology. IKDC, KOOS scales will be utilised for subjective evaluation. Clinical tests such as Lachman's, pivot shift, Appley's along with anterior tibial shift measurement with digital arthrometer for objective assessment will be also performed. Additionally isokinetic tests will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured .
Preliminary group of patients consists of 150 cases with follow-up at least 3 years, operated in age 12-17 years. All cases available for the study will be assessed with methodology above. Dedicated statistical test will be utilised to evaluate the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after ACL reconstruction in adolescence | Other | Procedure: Anterior cruciate ligament reconstruction |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age between 10-17 years at time of surgery
- ACL full thickness lesion
- meniscal lesions repaired simultaneously
- completed research protocol
Key exclusion criteria (4 listed)
- age <10 yo and >17 yo.
- PCL concomitant injury
- polytrauma
- other same knee surgeries performed before intervention
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 |
|---|---|---|
| Anterior cruciate ligament reconstructionAdolescent patients with confirmed full thickness ACL injury were operated arthroscopically with semitendinosus and gracilis autograft anatomical reconstruction. | Procedure or surgery | Patients after ACL reconstruction in adolescence |
Primary outcome
Lachman test
Time frame: up to six months
Assessment of knee stability in sagittal plane (positive/negative)
Pivot shift test
Time frame: up to six months
Assessment of knee rotational stability (positive/negative)
Apley's distraction test
Time frame: up to six months
Assessment of knee rotational stability (positive/negative)
MRI evaluation
Time frame: up to 12 months
Assessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) [cm3]
Isokinetic evaluation - peak torque
Time frame: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of peak torque (Newton-meter, [Nm])
Arthrometer testing
Time frame: up to six months
Assessment of knee stability in sagittal plane with digital arthrometer use (millimeters, [mm])
Isokinetic evaluation - torque at 30 deg
Time frame: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of torque at 30 deg (Newton-meter, [Nm])
Isokinetic evaluation - angle of peak torque
Time frame: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of angle of peak torque (degrees [deg]))
Isokinetic evaluation - time to peak torque
Time frame: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of time to peak torque (milliseconds [ms])
Isokinetic evaluation - work fatigue
Time frame: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of work fatigue (percent [%])
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Yes. Upon reasonable request via e-mail krzynormal@wp.pl
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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.
Krzysztof Małecki, Ph.D. study director
Polish Mother Memorial Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cruciate ligament reconstruction in people with ACL Injuries and Knee Instability, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
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 30 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 Poland. 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 Krzysztof Małecki, Ph.D. (+48 692043139, krzynormal@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lachman test (time frame: up to six months). The study lists 10 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 30 Apr 2024.