Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace
Return to Play After Anterior Cruciate Ligament Reconstruction With Bone Marrow Aspirate, Demineralized Bone Matrix, and an Internal Brace
1 other identifier
observational
450
1 country
1
Brief Summary
The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedStudy Start
First participant enrolled
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
March 5, 2024
February 1, 2024
2.4 years
February 19, 2024
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Return to play
Patient will be monitored for return to play at their sport
6 months after surgery until study conclusion
Biomechanics testing
Patient will undergo hop testing for limb symmetry
4.5 months after surgery and 6 months after surgery
Secondary Outcomes (1)
MRI findings
6 months after surgery
Other Outcomes (1)
Rerupture
2 years after surgery
Study Arms (2)
Treatment
These patients receive the surgery and are followed for two years for outcomes.
Control
These patients do not need and don't receive surgery and are followed for two years to compare to the surgery treatment group
Interventions
Fertilized ACL is an acl reconstruction with Bone marrow aspirate, demineralized bone matrix, and an internal brace.
Eligibility Criteria
patients 14-26 years old with ACL ruptures
You may qualify if:
- Patients must be age 14-26 years old.
- Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation.
- Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity
You may not qualify if:
- An understanding of the purpose of the study and providing written informed consent.
- Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
- Patients who have undergone previous ACL reconstructive surgery.
- Patients who are currently pregnant or nursing.
- Patients who have a current infection at the operative site.
- Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marshall Universitylead
- Arthrex, Inc.collaborator
Study Sites (1)
Marshall University
Huntington, West Virginia, 25755, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2024
First Posted
March 5, 2024
Study Start
February 26, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
July 1, 2028
Last Updated
March 5, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- from the start of the trial until the end date
Code - a HIPAA-compliant, encrypted database - will be used to store data and administer outcome questionnaires. At the time of informed consent, subjects will be assigned a study ID, which will be used to identify them throughout the study timeline. This HIPAA compliant data entry system will be utilized to store data throughout the study. After adequate follow-up, data will be downloaded for aggregate analysis. Outcome surveys will be emailed to subjects via Code, and subjects will complete them via a secure log-in to Code. All data transfer and data communication from the study doctor and subject to the sponsor takes place online over a secure, encrypted channel (SSL).