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Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair

NCT05494073 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-08

No results posted yet for this study

Summary

Patients between 14-60 years of age who will undergo an anterior cruciate ligament (ACL) reconstruction between Nov 1, 2021- Dec 31, 2023, will have their charts reviewed be approached in clinic when the surgery is scheduled regarding their participation in this study. At the time of consent, patients will be randomized to a group via a computerized randomization process, either the experimental hybrid remnant repair (HRR) or traditional ACL reconstruction with ACL stump debridement. Routine postoperative data will be collected at regularly scheduled post-operative and physical therapy appointments including range of motion, pain, patient-reported outcomes, return-to-sport tests, and proprioceptive data. Additionally, patients will be asked to undergo a post-operative MRI between 9 and 15 months following the date of their surgery. Radiologists reading the MRIs will be blinded to which group the patient is in. The primary outcome measure is graft incorporation between the two groups.

Conditions

  • Anterior Cruciate Ligament Tear

Interventions

PROCEDURE

ACL Reconstruction with Hybrid Remnant Repair

The intervention includes the incorporation of the host ACL remnant into the graft. The intervention hopefully

PROCEDURE

ACL Reconstruction without Hybrid Remnant Repair

ACL reconstruction without preservation or incorporation of host ACL remnant

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Vasilios Moutzouros, MD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2025-09-30
Completion
2026-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494073 on ClinicalTrials.gov