Clinical trial NCT05180123: Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
Official title: Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Injuries
Knee Instability
Keywords: Anterior cruciate ligament
ACL
Knee injuries
Adolescents
ACL injuries
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lachman test
timeFrame: up to six months
measure: Pivot shift test
timeFrame: up to six months
measure: Apley's distraction test
timeFrame: up to six months
measure: MRI evaluation
timeFrame: up to 12 months
measure: Isokinetic evaluation - peak torque
timeFrame: up to 12 months
measure: Arthrometer testing
timeFrame: up to six months
measure: Isokinetic evaluation - torque at 30 deg
timeFrame: up to 12 months
measure: Isokinetic evaluation - angle of peak torque
timeFrame: up to 12 months
measure: Isokinetic evaluation - time to peak torque
timeFrame: up to 12 months
measure: Isokinetic evaluation - work fatigue
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Polish Mother Memorial Hospital Research Institute
Study officials:
affiliation: Polish Mother Memorial Hospital Research Institute
name: Krzysztof Małecki, Ph.D.
role: STUDY_DIRECTOR
References: