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

• Sponsor: Polish Mother Memorial Hospital Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05180123
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ACL Injuries; Knee Instability	Procedure: Anterior cruciate ligament reconstruction	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients after ACL reconstruction in adolescence	Procedure: Anterior cruciate ligament reconstruction; Adolescent patients with confirmed full thickness ACL injury were operated arthroscopically with semitendinosus and gracilis autograft anatomical reconstruction.

Outcome Measures

Primary Outcome Measures

1. Lachman test [up to six months]

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

2. Pivot shift test [up to six months]

   Assessment of knee rotational stability (positive/negative)

3. Apley's distraction test [up to six months]

   Assessment of knee rotational stability (positive/negative)

4. MRI evaluation [up to 12 months]

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

5. Isokinetic evaluation - peak torque [up to 12 months]

   Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of peak torque (Newton-meter, [Nm])

6. Arthrometer testing [up to six months]

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

7. Isokinetic evaluation - torque at 30 deg [up to 12 months]

   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])

8. Isokinetic evaluation - angle of peak torque [up to 12 months]

   Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of angle of peak torque (degrees [deg]))

9. Isokinetic evaluation - time to peak torque [up to 12 months]

   Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of time to peak torque (milliseconds [ms])

10. Isokinetic evaluation - work fatigue [up to 12 months]

    Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of work fatigue (percent [%])

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Polish Mother Memorial Hospital Research Institute	Łódź		Poland	93-338

Sponsors and Collaborators

• Polish Mother Memorial Hospital Research Institute

Investigators

• Study Director: Krzysztof Małecki, Ph.D., Polish Mother Memorial Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Polish Mother Memorial Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT05180123
• Other Study ID Numbers: PMMHRI-BCO.37/2019-A
• First Posted: Jan 6, 2022
• Last Update Posted: Feb 18, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Polish Mother Memorial Hospital Research Institute: Anterior cruciate ligament; ACL; Knee injuries; Adolescents; ACL injuries
• Additional relevant MeSH terms: Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Feb 18, 2022