CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
OOCdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04993339
NCT04993339Phase 3Completed
CompareCT.gov

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

University of Miami·interventional·Posted Aug 6, 2021·Updated Sep 5, 2021

In Brief

A Phase 3 clinical trial evaluating OOC for ACL Injury. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsACL Injury
CountriesUnited States
CollaboratorsArthrex, Inc.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 6, 2021
Enrollment StartOct 24, 2016
Primary CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 4.9 years ago

Interventions

OOCdrug

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