At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 67 enrolled
Drug / intervention
ACL reconstruction control +1 moreprocedure
Likely dose
BioCleanse-processed patellar tendon allograft for ACL reconstruction (dose/volume not specified)AI-extracted
Key inclusion· 1
- ✓Candidate for ACL reconstruction
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
In Brief
A Phase 4 clinical trial evaluating ACL reconstruction control and ACL Biocleanse, surgical for Anterior Cruciate Ligament Tear. Completed, enrolled 67 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnterior Cruciate Ligament Tear
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
First PostedSep 2005
Primary CompletionDec 2012
TodayJul 2026
First PostedSep 16, 2005
Enrollment StartFeb 1, 2004
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.8 years ago
Interventions
ACL reconstruction controlprocedure
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgicalprocedure
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.