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Procedure

ACL Reconstruction for ACL Injury

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post aclr

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-operative imaging (MRI) graft incorporation

Secondary outcome measures

Patient-reported outcomes (PROMIS forms)

Return-to-sport (time from surgery)

Subject proprioceptive ability

+2 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,899 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility requirements to participate in this medical research?

"To qualify for this medical experiment, participants must have suffered an anterior cruciate ligament tear and be aged between 13-65. The trial is searching to include a total of 100 individuals in their research."

Answered by AI

Is participation in this clinical experiment still open to new recruits?

"This clinical trial is currently enrolling participants, having first been advertised on December 13th 2021 and most recently modified on August 7th 2022."

Answered by AI

Does this study allow individuals of more advanced age to participate?

"In order to enroll in the current study, patients must be between 13 and 65 years old. Furthermore, there are additional trials for participants below 18 (47) or over 65 (25)."

Answered by AI

What is the total participant capacity of this scientific experiment?

"Affirmative. Details supplied on clinicaltrials.gov confirm that this medical experiment, initially posted in December 2021, is actively seeking enrolment from participants. 100 individuals are being recruited for the trial at a single site."

Answered by AI

Recent research and studies

Revista Brasileira de OrtopediaJournal

Retorno ao esporte após reconstrução do LCA com ressecção ou preservação do remanescente

Diaz, Ruben Marcelo Maldonado, Fernando Cury Rezende, Antonio Carlos Moscon, Carlos Eduardo da Silveira Franciozi, Ana Luiza Cabrera Martimbianco, and Aires Duarte Junior. 2020. “Retorno ao esporte após reconstrução do LCA com ressecção ou preservação do remanescente”. Revista brasileira de ortopedia. Georg Thieme Verlag KG. doi:10.1055/s-0039-3402461.

Clinical Orthopaedics & Related ResearchJournal

Hamstring Autograft Versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients

Samuelsen, Brian T., Kate E. Webster, Nick R. Johnson, Timothy E. Hewett, and Aaron J. Krych. 2017. “Hamstring Autograft Versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients”. Clinical Orthopaedics & Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s11999-017-5278-9.

Arthroscopy TechniquesJournal

Anatomical Remnant-preserving Double-bundle ACL Reconstruction with a New Remnant Augmentation Technique

Tensho, Keiji, Tomoya Iwaasa, Hiroki Shimodaira, Suguru Koyama, Hiroshi Horiuchi, Jun Takahashi, and Naoto Saito. 2020. “Anatomical Remnant-preserving Double-bundle ACL Reconstruction with a New Remnant Augmentation Technique”. Arthroscopy Techniques. Elsevier BV. doi:10.1016/j.eats.2019.10.009.

The Bone & Joint JournalJournal