Phase 3
Completed N=26
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
ACL Injury
Source: ClinicalTrials.gov NCT04993339 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Number of Participants With Bone Tunnel Expansion — 0; 4; 10; 6 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Bone Tunnel Expansion |
0; 4; 10; 6; 1; 0 | — |
| SECONDARY Graft Maturation |
4.28; 2.28 | — |
| SECONDARY Number of Participants With Tunnel Ganglion Cyst Formation |
8; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04993339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.