Trials / Completed
CompletedNCT04993339
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-10-24
- Primary completion
- 2020-02-20
- Completion
- 2020-02-20
- First posted
- 2021-08-06
- Last updated
- 2021-09-05
- Results posted
- 2021-09-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04993339. Inclusion in this directory is not an endorsement.