Knee Instability Clinical Trial
Official title:
Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Polish Mother Memorial Hospital Research Institute | Lódz |
Lead Sponsor | Collaborator |
---|---|
Polish Mother Memorial Hospital Research Institute |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lachman test | Assessment of knee stability in sagittal plane (positive/negative) | up to six months | |
Primary | Pivot shift test | Assessment of knee rotational stability (positive/negative) | up to six months | |
Primary | Apley's distraction test | Assessment of knee rotational stability (positive/negative) | up to six months | |
Primary | MRI evaluation | Assessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) [cm3] | up to 12 months | |
Primary | 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]) | up to 12 months | |
Primary | Arthrometer testing | Assessment of knee stability in sagittal plane with digital arthrometer use (millimeters, [mm]) | up to six months | |
Primary | 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]) | up to 12 months | |
Primary | 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])) | up to 12 months | |
Primary | 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]) | up to 12 months | |
Primary | 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 [%]) | up to 12 months |
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