Phase 4
N=67
Evaluation of Biocleanse Allografts For ACL Reconstruction
Anterior Cruciate Ligament Tear
Bottom Line
View on ClinicalTrials.gov: NCT00187876 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: International Knee Documentation Committee (IKDC) Form — 89; 88 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ACL reconstruction control (Procedure); ACL Biocleanse, surgical (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Knee Documentation Committee (IKDC) Form |
89; 88 | — |
Summary
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.
Eligibility Criteria
Inclusion Criteria
- ACL reconstruction
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT00187876). 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.