Trial Outcomes & Findings for Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound (NCT NCT04993339)
NCT ID: NCT04993339
Last Updated: 2021-09-05
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
up to 12 months post-surgery
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
Standard Surgery
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Standard Surgery
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
no MRI scan
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Surgery
n=14 Participants
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
|
Standard Surgery With OOC
n=12 Participants
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
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=14 Participants
|
12 Participants
n=12 Participants
|
26 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=14 Participants
|
5 Participants
n=12 Participants
|
12 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants
|
7 Participants
n=12 Participants
|
14 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: up to 12 months post-surgeryNumber 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)
Outcome measures
| Measure |
Standard Surgery
n=11 Participants
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
|
Standard Surgery With OOC
n=10 Participants
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
|
|---|---|---|
|
Number of Participants With Bone Tunnel Expansion
femoral minimal expansion
|
0 Participants
|
4 Participants
|
|
Number of Participants With Bone Tunnel Expansion
femoral mild expansion
|
10 Participants
|
6 Participants
|
|
Number of Participants With Bone Tunnel Expansion
femoral moderate expansion
|
1 Participants
|
0 Participants
|
|
Number of Participants With Bone Tunnel Expansion
femoral large expansion
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bone Tunnel Expansion
tibial minimal expansion
|
0 Participants
|
3 Participants
|
|
Number of Participants With Bone Tunnel Expansion
tibial mild expansion
|
8 Participants
|
7 Participants
|
|
Number of Participants With Bone Tunnel Expansion
tibial moderate expansion
|
2 Participants
|
0 Participants
|
|
Number of Participants With Bone Tunnel Expansion
tibial large expansion
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 12 months post-surgeryas measured in millimeters via Magnetic Resonance Imaging (MRI)
Outcome measures
| Measure |
Standard Surgery
n=11 Participants
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
|
Standard Surgery With OOC
n=10 Participants
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
|
|---|---|---|
|
Graft Maturation
|
4.28 millimeters
Standard Deviation 2.55
|
2.28 millimeters
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: up to 12 months post-surgeryas measured via Magnetic Resonance Imaging (MRI)
Outcome measures
| Measure |
Standard Surgery
n=11 Participants
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
|
Standard Surgery With OOC
n=10 Participants
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
|
|---|---|---|
|
Number of Participants With Tunnel Ganglion Cyst Formation
|
8 Participants
|
2 Participants
|
Adverse Events
Standard Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Surgery With OOC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place