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

Phase 3

Completed

• Conditions: ACL Injury
• Interventions: Drug: OOC

• Registration Number: NCT04993339
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-24
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Status Verified: 2021-08
• Study First Posted: 2021-08-06
• Results First Submitted: 2021-08-10
• Results First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Results First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Surgery with OOC	OOC	Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention

Primary Outcome Measures

Name	Time	Method
Number of Participants With Bone Tunnel Expansion	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 Outcome Measures

Name	Time	Method
Graft Maturation	up to 12 months post-surgery	as measured in millimeters via Magnetic Resonance Imaging (MRI)
Number of Participants With Tunnel Ganglion Cyst Formation	up to 12 months post-surgery	as measured via Magnetic Resonance Imaging (MRI)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States