Evaluating ACL Reconstruction Results in Adolescents After 3 Years
Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
This study is testing how well ACL surgery works for kids and teens aged 10 to 17 over three years, looking at their recovery and any early signs of knee problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Polish Mother Memorial Hospital Research Institute Academic / other |
| Locations | 1 site (Łódź) |
| Trial ID | NCT05180123 on ClinicalTrials.gov |
What this trial studies
This study evaluates the outcomes of anterior cruciate ligament (ACL) reconstruction in adolescents aged 10 to 17 years, focusing on both clinical and MRI assessments. It aims to determine the functional results and any early signs of osteoarthritis following surgery, with a follow-up period of at least three years. The study will utilize subjective evaluation scales such as IKDC and KOOS, alongside objective clinical tests and isokinetic assessments to measure recovery and knee stability. The findings will help understand the effectiveness of ACL reconstruction in this age group.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 10 to 17 years who have undergone ACL reconstruction and have a full thickness ACL lesion.
Not a fit: Patients younger than 10 years or older than 17 years, or those with concomitant PCL injuries or previous knee surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term outcomes of ACL reconstruction in adolescents, potentially improving treatment protocols.
How similar studies have performed: While there is existing literature on ACL injuries in adolescents, this specific evaluation of long-term outcomes through both clinical and MRI assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Łódź
- Polish Mother Memorial Hospital Research Institute — Łódź, Poland (Recruiting)
Study contacts
- Study coordinator: Krzysztof Małecki, Ph.D.
- Email: krzynormal@wp.pl
- Phone: +48 692043139
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.