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Procedure

ACL Reconstruction for ACL Injury

N/A
Waitlist Available
Led By Vasilios Moutzouros, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post aclr
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new method of ACL reconstruction against the traditional method to see if the new method results in better graft incorporation. Patients between 14-60 years of age who will undergo ACL reconstruction between Nov 1, 2021 and Dec 31, 2023 will be approached to participate. Patients will be randomized to either the experimental group or the traditional group, and data will be collected at regularly scheduled post-operative and physical therapy appointments. Additionally, patients will have an MRI 9-15 months after surgery. The primary outcome measure is graft incorporation between the two groups.

Who is the study for?
This trial is for individuals aged 14-65 who need ACL reconstruction surgery due to injury or tear, and can attend follow-up appointments. It's not suitable for those with additional ligament injuries (MCL, LCL, PCL) or who won't have the specific HRR technique.
What is being tested?
The study compares two ACL reconstruction methods: one using Hybrid Remnant Repair (HRR) and the other a traditional approach without HRR. Participants are randomly assigned to either group and monitored through post-op visits and MRI scans.
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects of ACL surgery may include pain, swelling, limited range of motion, infection risk at the incision site, blood clots, stiffness or weakness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post aclr
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post aclr for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-operative imaging (MRI) graft incorporation
Secondary study objectives
Patient-reported outcomes (PROMIS forms)
Return-to-sport (time from surgery)
Subject proprioceptive ability
+2 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hybrid Remnant RepairExperimental Treatment1 Intervention
Patients in this arm will have an ACL reconstruction with preservation and incorporation of the the ACL remnant.
Group II: ControlActive Control1 Intervention
Patients in this arm will have a ACL reconstruction where the ACL remnant is not incorporated into the graft.

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,293 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Tear
50 Patients Enrolled for Anterior Cruciate Ligament Tear
Vasilios Moutzouros, MDPrincipal InvestigatorHenry Ford Health System

Media Library

ACL Reconstruction with Hybrid Remnant Repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05494073 — N/A
Anterior Cruciate Ligament Tear Research Study Groups: Hybrid Remnant Repair, Control
Anterior Cruciate Ligament Tear Clinical Trial 2023: ACL Reconstruction with Hybrid Remnant Repair Highlights & Side Effects. Trial Name: NCT05494073 — N/A
ACL Reconstruction with Hybrid Remnant Repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05494073 — N/A
~3 spots leftby Mar 2025
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