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Phase 4 N=67 Randomized Treatment

Evaluation of Biocleanse Allografts For ACL Reconstruction

Anterior Cruciate Ligament Tear

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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