Phase 3 N=26 Randomized Single-blind Treatment

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

ACL Injury

Bottom Line

View on ClinicalTrials.gov: NCT04993339 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Number of Participants With Bone Tunnel Expansion — 0; 4; 10; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: OOC (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Bone Tunnel Expansion	0; 4; 10; 6; 1; 0	—
SECONDARY Graft Maturation	4.28; 2.28	—
SECONDARY Number of Participants With Tunnel Ganglion Cyst Formation	8; 2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04993339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.