Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
Overview
- Phase
- Phase 3
- Intervention
- OOC
- Conditions
- ACL Injury
- Sponsor
- University of Miami
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Number of Participants With Bone Tunnel Expansion
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Francesco Travascio
Associate Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •any adult undergoing a surgical procedure for hamstring ACL reconstruction
Exclusion Criteria
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
Arms & Interventions
Standard Surgery with OOC
Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention
Intervention: OOC
Outcomes
Primary Outcomes
Number of Participants With Bone Tunnel Expansion
Time Frame: up to 12 months post-surgery
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)
Secondary Outcomes
- Graft Maturation(up to 12 months post-surgery)
- Number of Participants With Tunnel Ganglion Cyst Formation(up to 12 months post-surgery)