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

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 Overview

• Status: Completed
• Conditions: ACL Injury
• Intervention / Treatment: Drug: OOC

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Surgery; Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
Experimental: Standard Surgery with OOC; Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional 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; Other Names: StimuBlast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Arthrex, Inc.
• Investigators: Principal Investigator: Francesco Travascio, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2016
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 20150981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No