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

NCT05180123 | Recruiting

• 1 other identifier: PMMHRI-BCO.37/2019-A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Anterior cruciate ligament; ACL; Knee injuries; Adolescents; ACL injuries

Outcome Measures

Primary Outcomes (10)

• Lachman test

  Assessment of knee stability in sagittal plane (positive/negative)

  up to six months

• Pivot shift test

  Assessment of knee rotational stability (positive/negative)

  up to six months

• Apley's distraction test

  Assessment of knee rotational stability (positive/negative)

  up to six months

• MRI evaluation

  Assessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) \[cm3\]

  up to 12 months

• 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

• Arthrometer testing

  Assessment of knee stability in sagittal plane with digital arthrometer use (millimeters, \[mm\])

  up to six months

• 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

• 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

• 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

• 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

Study Arms (1)

Patients after ACL reconstruction in adolescence

OTHER

Procedure: Anterior cruciate ligament reconstruction

Interventions

Anterior cruciate ligament reconstruction PROCEDURE

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

Patients after ACL reconstruction in adolescence

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 10-17 years at time of surgery
• ACL full thickness lesion
• meniscal lesions repaired simultaneously
• completed research protocol

You may not qualify if:

• age \<10 yo and \>17 yo.
• PCL concomitant injury
• polytrauma
• other same knee surgeries performed before intervention

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

Polish Mother Memorial Hospital Research Institute

Lodz, 93-338, Poland

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Krzysztof Małecki, Ph.D.

  Polish Mother Memorial Hospital Research Institute

  STUDY DIRECTOR

Central Study Contacts

Krzysztof Małecki, Ph.D.

CONTACT

+48 692043139; krzynormal@wp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: December 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2022-2028
• Access Criteria: krzynormal@wp.pl

Locations

PL (1)