ACL Injury
Conditions
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.
Interventions
DRUGOOC
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
Sponsors
Arthrex, Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bone Tunnel Expansion | 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
| Measure | Time frame | Description |
|---|---|---|
| Graft Maturation | up to 12 months post-surgery | as measured in millimeters via Magnetic Resonance Imaging (MRI) |
| Number of Participants With Tunnel Ganglion Cyst Formation | up to 12 months post-surgery | as measured via Magnetic Resonance Imaging (MRI) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Surgery Participants in this group undergoing standard of care reparative surgery will not receive additional intervention | 14 |
| 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 | 12 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | no MRI scan | 3 | 1 |
Baseline characteristics
| Characteristic | Standard Surgery | Standard Surgery With OOC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 12 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 0 / 14 | 0 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 |
Outcome results
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)
Time frame: up to 12 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | femoral minimal expansion | 0 Participants |
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | femoral moderate expansion | 1 Participants |
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | tibial mild expansion | 8 Participants |
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | tibial minimal expansion | 0 Participants |
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | tibial moderate expansion | 2 Participants |
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | femoral large expansion | 0 Participants |
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | tibial large expansion | 1 Participants |
| Standard Surgery | Number of Participants With Bone Tunnel Expansion | femoral mild expansion | 10 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | tibial large expansion | 0 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | femoral minimal expansion | 4 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | femoral mild expansion | 6 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | femoral moderate expansion | 0 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | femoral large expansion | 0 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | tibial minimal expansion | 3 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | tibial mild expansion | 7 Participants |
| Standard Surgery With OOC | Number of Participants With Bone Tunnel Expansion | tibial moderate expansion | 0 Participants |
Secondary
Graft Maturation
as measured in millimeters via Magnetic Resonance Imaging (MRI)
Time frame: up to 12 months post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Surgery | Graft Maturation | 4.28 millimeters | Standard Deviation 2.55 |
| Standard Surgery With OOC | Graft Maturation | 2.28 millimeters | Standard Deviation 1.97 |
Secondary
Number of Participants With Tunnel Ganglion Cyst Formation
as measured via Magnetic Resonance Imaging (MRI)
Time frame: up to 12 months post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Surgery | Number of Participants With Tunnel Ganglion Cyst Formation | 8 Participants |
| Standard Surgery With OOC | Number of Participants With Tunnel Ganglion Cyst Formation | 2 Participants |