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

NCT ID: NCT05180123

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-12-30

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.

Conditions

ACL Injuries; Knee Instability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients after ACL reconstruction in adolescence

Group Type: OTHER

Anterior cruciate ligament reconstruction

Intervention Type: PROCEDURE

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

Interventions

Anterior cruciate ligament reconstruction

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krzysztof Małecki, Ph.D.

Role: STUDY_DIRECTOR

Polish Mother Memorial Hospital Research Institute

Locations

Polish Mother Memorial Hospital Research Institute

Lodz, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Krzysztof Małecki, Ph.D.

Role: CONTACT

krzynormal@wp.pl

+48 692043139

Facility Contacts

Krzysztof Małecki, Ph.D.

Role: primary

krzynormal@wp.pl

+48 692043139

Other Identifiers

PMMHRI-BCO.37/2019-A

Identifier Type: -

Identifier Source: org_study_id