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NCT04993339 Clinical Trial

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

ACL Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04993339
Other study ID # 20150981
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 24, 2016
Est. completion date February 20, 2020

Study information
Verified date August 2021
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date February 20, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

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

Locations
Country Name City State
United States University of Miami Coral Gables Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Miami Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Graft Maturation as measured in millimeters via Magnetic Resonance Imaging (MRI) up to 12 months post-surgery
Secondary Number of Participants With Tunnel Ganglion Cyst Formation as measured via Magnetic Resonance Imaging (MRI) up to 12 months post-surgery
See also
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Recruiting NCT06206200 - The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After ACL Reconstruction N/A
Active, not recruiting NCT06167343 - Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction N/A
Completed NCT04541940 - TeleRehabilitation Following ACL Reconstruction N/A
Terminated NCT03497780 - Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:
Completed NCT04967937 - Neuromuscular Training Improves Single-Limb Stability N/A
Recruiting NCT04901858 - Knee Aspiration and High Definition MRI for ACL Injury N/A
Completed NCT02602561 - Effects of HMB Supplementation on Recovery Following ACL Surgery N/A