Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound

ACL Injury Clinical Trial

Official title:

Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993339
• Other study ID #: 20150981
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2016
• Est. completion date: February 20, 2020

Study information

• Verified date: August 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Drug:
• OOC
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

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Graft Maturation	as measured in millimeters via Magnetic Resonance Imaging (MRI)	up to 12 months post-surgery
Secondary	Number of Participants With Tunnel Ganglion Cyst Formation	as measured via Magnetic Resonance Imaging (MRI)	up to 12 months post-surgery