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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Surgery | No Intervention | Participants in this group undergoing standard of care reparative surgery will not receive additional intervention | |
| Standard Surgery with OOC | Experimental | Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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:
as measured via Magnetic Resonance Imaging (MRI) | up to 12 months post-surgery |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Travascio | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Coral Gables | Florida | 33146 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Surgery | Participants in this group undergoing standard of care reparative surgery will not receive additional intervention |
| FG001 | Standard Surgery With OOC | Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Surgery | Participants in this group undergoing standard of care reparative surgery will not receive additional intervention |
| BG001 | Standard Surgery With OOC | Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Bone Tunnel Expansion | Number of participants will be classified with having femoral and tibial tunnel expansion as:
as measured via Magnetic Resonance Imaging (MRI) | Posted | Count of Participants | Participants | up to 12 months post-surgery |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Surgery | Participants in this group undergoing standard of care reparative surgery will not receive additional intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francesco Travascio | University of Miami | 3052842371 | f.travascio@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2017 | Aug 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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|
| up to 12 months post-surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Graft Maturation | as measured in millimeters via Magnetic Resonance Imaging (MRI) | Posted | Mean | Standard Deviation | millimeters | up to 12 months post-surgery |
|
|
|
| Secondary | Number of Participants With Tunnel Ganglion Cyst Formation | as measured via Magnetic Resonance Imaging (MRI) | Posted | Count of Participants | Participants | up to 12 months post-surgery |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Standard Surgery With OOC | Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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