Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
Primary Purpose
ACL Injuries, Knee Instability
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Anterior cruciate ligament reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for ACL Injuries focused on measuring Anterior cruciate ligament, ACL, Knee injuries, Adolescents, ACL injuries
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
Sites / Locations
- Polish Mother Memorial Hospital Research InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients after ACL reconstruction in adolescence
Arm Description
Outcomes
Primary Outcome Measures
Lachman test
Assessment of knee stability in sagittal plane (positive/negative)
Pivot shift test
Assessment of knee rotational stability (positive/negative)
Apley's distraction test
Assessment of knee rotational stability (positive/negative)
MRI evaluation
Assessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) [cm3]
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])
Arthrometer testing
Assessment of knee stability in sagittal plane with digital arthrometer use (millimeters, [mm])
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])
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]))
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])
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 [%])
Secondary Outcome Measures
Full Information
NCT ID
NCT05180123
First Posted
December 17, 2021
Last Updated
February 13, 2023
Sponsor
Polish Mother Memorial Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05180123
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polish Mother Memorial Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injuries, Knee Instability
Keywords
Anterior cruciate ligament, ACL, Knee injuries, Adolescents, ACL injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients after ACL reconstruction in adolescence
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Anterior cruciate ligament reconstruction
Intervention Description
Adolescent patients with confirmed full thickness ACL injury were operated arthroscopically with semitendinosus and gracilis autograft anatomical reconstruction.
Primary Outcome Measure Information:
Title
Lachman test
Description
Assessment of knee stability in sagittal plane (positive/negative)
Time Frame
up to six months
Title
Pivot shift test
Description
Assessment of knee rotational stability (positive/negative)
Time Frame
up to six months
Title
Apley's distraction test
Description
Assessment of knee rotational stability (positive/negative)
Time Frame
up to six months
Title
MRI evaluation
Description
Assessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) [cm3]
Time Frame
up to 12 months
Title
Isokinetic evaluation - peak torque
Description
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of peak torque (Newton-meter, [Nm])
Time Frame
up to 12 months
Title
Arthrometer testing
Description
Assessment of knee stability in sagittal plane with digital arthrometer use (millimeters, [mm])
Time Frame
up to six months
Title
Isokinetic evaluation - torque at 30 deg
Description
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])
Time Frame
up to 12 months
Title
Isokinetic evaluation - angle of peak torque
Description
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of angle of peak torque (degrees [deg]))
Time Frame
up to 12 months
Title
Isokinetic evaluation - time to peak torque
Description
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of time to peak torque (milliseconds [ms])
Time Frame
up to 12 months
Title
Isokinetic evaluation - work fatigue
Description
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of work fatigue (percent [%])
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof Małecki, Ph.D.
Phone
+48 692043139
Email
krzynormal@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Małecki, Ph.D.
Organizational Affiliation
Polish Mother Memorial Hospital Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Polish Mother Memorial Hospital Research Institute
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof Małecki, Ph.D.
Phone
+48 692043139
Email
krzynormal@wp.pl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request via e-mail krzynormal@wp.pl
IPD Sharing Time Frame
2022-2028
IPD Sharing Access Criteria
krzynormal@wp.pl
Learn more about this trial
Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
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