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Procedure

ACL Reconstruction Techniques for Anterior Cruciate Ligament Injury

N/A
Recruiting
Led By Stephanie Mayer, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ages 12 to 19 (inclusive)
Patients undergoing primary ACL reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two methods of ACL reconstruction in kids to see which is better in the short, intermediate, and long term.

Who is the study for?
This trial is for boys and girls aged 12-19 who need their first ACL reconstruction due to injury or tear. It's not for those with neuromuscular issues, neurological injuries, recent severe leg trauma, or systemic/musculoskeletal conditions.
What is being tested?
The study compares two surgical techniques for pediatric ACL reconstruction: one using a tendon-bone graft and the other an all-tendon graft. The goal is to see which method leads to better outcomes in the short, medium, and long term.
What are the potential side effects?
While specific side effects are not listed here, typical risks of ACL surgery may include pain at the graft site, infection risk post-surgery, stiffness or loss of motion in the knee joint.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 19 years old.
Select...
I am having my first ACL surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Long-Term Graft Superiority
Short-Term Graft Superiority
Secondary study objectives
Patient Reported Outcomes
Time to Return to Sports Rates

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Tendon-Bone GraftActive Control1 Intervention
Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.
Group II: All-Soft-Tissue GraftActive Control1 Intervention
Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,830 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
178 Patients Enrolled for Anterior Cruciate Ligament Injury
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,041 Total Patients Enrolled
Stephanie Mayer, MDPrincipal InvestigatorChildren's Hospital Colorado

Media Library

ACL Reconstruction (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04039971 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Tendon-Bone Graft, All-Soft-Tissue Graft
Anterior Cruciate Ligament Injury Clinical Trial 2023: ACL Reconstruction Highlights & Side Effects. Trial Name: NCT04039971 — N/A
ACL Reconstruction (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04039971 — N/A
~76 spots leftby Aug 2029