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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05180123
Other study ID # PMMHRI-BCO.37/2019-A
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date December 30, 2025

Study information

Verified date April 2024
Source Polish Mother Memorial Hospital Research Institute
Contact Krzysztof Malecki, Ph.D.
Phone +48 692043139
Email krzynormal@wp.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Anterior cruciate ligament reconstruction
Adolescent patients with confirmed full thickness ACL injury were operated arthroscopically with semitendinosus and gracilis autograft anatomical reconstruction.

Locations

Country Name City State
Poland Polish Mother Memorial Hospital Research Institute Lódz

Sponsors (1)

Lead Sponsor Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

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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