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

Knee Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180123
• Other study ID #: PMMHRI-BCO.37/2019-A
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Knee Instability

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