search
Back to results

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

Primary Purpose

ACL Injury

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OOC
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Surgery

Standard Surgery with OOC

Arm Description

Participants in this group undergoing standard of care reparative surgery will not receive additional intervention

Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Graft Maturation
as measured in millimeters via Magnetic Resonance Imaging (MRI)
Number of Participants With Tunnel Ganglion Cyst Formation
as measured via Magnetic Resonance Imaging (MRI)

Full Information

First Posted
July 28, 2021
Last Updated
August 10, 2021
Sponsor
University of Miami
Collaborators
Arthrex, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04993339
Brief Title
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
Official Title
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 24, 2016 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Arthrex, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Surgery
Arm Type
No Intervention
Arm Description
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
Arm Title
Standard Surgery with OOC
Arm Type
Experimental
Arm Description
Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention
Intervention Type
Drug
Intervention Name(s)
OOC
Other Intervention Name(s)
StimuBlast
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Bone Tunnel Expansion
Description
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)
Time Frame
up to 12 months post-surgery
Secondary Outcome Measure Information:
Title
Graft Maturation
Description
as measured in millimeters via Magnetic Resonance Imaging (MRI)
Time Frame
up to 12 months post-surgery
Title
Number of Participants With Tunnel Ganglion Cyst Formation
Description
as measured via Magnetic Resonance Imaging (MRI)
Time Frame
up to 12 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Travascio
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs