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Internal Brace for Anterior Cruciate Ligament Injury
N/A
Recruiting
Led By Guillem Gonzalez-Lomas, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 12 post-operation
Awards & highlights
Study Summary
This trial aims to evaluate the healing of the ACL after surgery by looking at different outcomes such as clinical tests, X-rays, physical function, and patient-reported experiences. Researchers will compare the results between patients
Who is the study for?
This trial is for individuals who have injured their anterior cruciate ligament (ACL) and are undergoing ACL reconstruction. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.Check my eligibility
What is being tested?
The study is examining the healing process of the ACL after reconstruction using a quadriceps graft. It compares outcomes with and without the use of an Arthrex Internal Brace, which may provide additional support during healing.See study design
What are the potential side effects?
Potential side effects were not detailed in the provided information. However, common side effects from similar procedures can include pain at the surgery site, swelling, infection risk, and possible knee stiffness or weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 12 post-operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 12 post-operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation
Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation
Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Internal BraceExperimental Treatment2 Interventions
Patients will undergo ACL Reconstruction (ACLR) with an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.
Group II: Standard ACLRActive Control1 Intervention
Patients will undergo ACLR without an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACL Reconstruction
2016
N/A
~20
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,568 Total Patients Enrolled
Guillem Gonzalez-Lomas, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
250 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for potential participants in this research study?
"Data from clinicaltrials.gov shows that this specific medical trial is presently not accepting new participants. The initial posting date was 2/26/2024 with the most recent update on 2/23/2024. While recruitment is currently paused, there are a total of 93 other ongoing trials seeking candidates for enrollment."
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