Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
1 other identifier
interventional
26
1 country
1
Brief Summary
The goal of this study is to determine whether the use of injectable osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL) reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides clinical outcomes superior to those attained via traditional ACL reconstruction and delayed rehabilitation protocols.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2016
Typical duration for phase_3
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
Study Start
First participant enrolled
October 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedFirst Submitted
Initial submission to the registry
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedResults Posted
Study results publicly available
September 5, 2021
CompletedSeptember 5, 2021
August 1, 2021
3.3 years
July 28, 2021
August 10, 2021
August 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Bone Tunnel Expansion
Number of participants will be classified with having femoral and tibial tunnel expansion as: * minimal expansion (\<1mm) * mild expansion (\<5mm) * moderate expansion (5-10mm) * large expansion (\>10mm) as measured via Magnetic Resonance Imaging (MRI)
up to 12 months post-surgery
Secondary Outcomes (2)
Graft Maturation
up to 12 months post-surgery
Number of Participants With Tunnel Ganglion Cyst Formation
up to 12 months post-surgery
Study Arms (2)
Standard Surgery
NO INTERVENTIONParticipants in this group undergoing standard of care reparative surgery will not receive additional intervention
Standard Surgery with OOC
EXPERIMENTALParticipants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention
Interventions
The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels
Eligibility Criteria
You may qualify if:
- any adult undergoing a surgical procedure for hamstring ACL reconstruction
You may not qualify if:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Arthrex, Inc.collaborator
Study Sites (1)
University of Miami
Coral Gables, Florida, 33146, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Francesco Travascio
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Travascio
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 28, 2021
First Posted
August 6, 2021
Study Start
October 24, 2016
Primary Completion
February 20, 2020
Study Completion
February 20, 2020
Last Updated
September 5, 2021
Results First Posted
September 5, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share