Skip to content

Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.

Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05180123
Enrollment
150
Registered
2022-01-06
Start date
2021-12-01
Completion date
2025-12-30
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Injuries, Knee Instability

Keywords

Anterior cruciate ligament, ACL, Knee injuries, Adolescents, ACL injuries

Brief 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. 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.

Interventions

PROCEDUREAnterior cruciate ligament reconstruction

Adolescent patients with confirmed full thickness ACL injury were operated arthroscopically with semitendinosus and gracilis autograft anatomical reconstruction.

Sponsors

Polish Mother Memorial Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* age between 10-17 years at time of surgery * ACL full thickness lesion * meniscal lesions repaired simultaneously * completed research protocol

Exclusion criteria

* age \<10 yo and \>17 yo. * PCL concomitant injury * polytrauma * other same knee surgeries performed before intervention

Design outcomes

Primary

MeasureTime frameDescription
Lachman testup to six monthsAssessment of knee stability in sagittal plane (positive/negative)
Pivot shift testup to six monthsAssessment of knee rotational stability (positive/negative)
Apley's distraction testup to six monthsAssessment of knee rotational stability (positive/negative)
MRI evaluationup to 12 monthsAssessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) \[cm3\]
Isokinetic evaluation - peak torqueup to 12 monthsQuadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of peak torque (Newton-meter, \[Nm\])
Arthrometer testingup to six monthsAssessment of knee stability in sagittal plane with digital arthrometer use (millimeters, \[mm\])
Isokinetic evaluation - torque at 30 degup to 12 monthsQuadriceps 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 torqueup to 12 monthsQuadriceps 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 torqueup to 12 monthsQuadriceps 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 fatigueup to 12 monthsQuadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of work fatigue (percent \[%\])

Countries

Poland

Contacts

Primary ContactKrzysztof Małecki, Ph.D.
krzynormal@wp.pl+48 692043139

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026