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OpenTrials
Completed

NCT Number: NCT04993339

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.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OOC

Drug

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

Primary outcomes

  1. Number of Participants With Bone Tunnel Expansion

    Time frame: 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 outcomes

  1. Graft Maturation

    Time frame: up to 12 months post-surgery

    as measured in millimeters via Magnetic Resonance Imaging (MRI)

  2. Number of Participants With Tunnel Ganglion Cyst Formation

    Time frame: up to 12 months post-surgery

    as measured via Magnetic Resonance Imaging (MRI)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Arthrex, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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