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NCT05494073 · ClinicalTrials.gov registry record · NA
Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair
A NA study of Anterior Cruciate Ligament Tear, sponsored by Henry Ford Health System.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05494073: Active NA study of Anterior Cruciate Ligament Tear, sponsored by Henry Ford Health System.
NCT05494073 is a NA study of Anterior Cruciate Ligament Tear that is active but no longer recruiting, run by Henry Ford Health System. The registered enrollment target is 100 participants, below the 221-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05494073, a NA study of Anterior Cruciate Ligament Tear, is active but no longer recruiting, sponsored by Henry Ford Health System.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
We hypothesize patients undergoing HRR ACLR will have better incorporation with improved vascularity compared to patients undergoing a traditional ACLR. We hypothesize that this will lead to improved proprioceptive abilities and improved patient reported outcomes, which may reduce the time required to be cleared to return-to-sport and resume usual activities of daily living.
Conditions Studied
Interventions
- PROCEDURE ACL Reconstruction with Hybrid Remnant Repair
- PROCEDURE ACL Reconstruction without Hybrid Remnant Repair
Study Locations (1)
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2026-11 |
| Phase | NA |
What the registry record for NCT05494073 still lists
NCT05494073 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Anterior Cruciate Ligament Tear appearing as the primary indexed condition, and to 2 interventions - of which ACL Reconstruction with Hybrid Remnant Repair is the first listed.
NCT05494073 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05494073 about?
NCT05494073 is a clinical study titled "Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair". 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, patien...
What is the current status of trial NCT05494073?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-12-13. Estimated completion is 2026-11.
What conditions does trial NCT05494073 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Tear.
What interventions are being tested in trial NCT05494073?
The interventions under investigation include: ACL Reconstruction with Hybrid Remnant Repair (PROCEDURE), ACL Reconstruction without Hybrid Remnant Repair (PROCEDURE).
Who is sponsoring clinical trial NCT05494073?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05494073 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05494073's enrollment target sits among peer trials
100 5th of 11 higher than 6 of 11 other Anterior Cruciate Ligament Tear trials
participants (enrollment target), bucketed by value
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