Evaluation of Biocleanse Allografts For ACL Reconstruction
Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
1 other identifier
interventional
67
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
March 4, 2014
CompletedMarch 4, 2014
January 1, 2014
8.8 years
September 12, 2005
December 4, 2013
January 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
International Knee Documentation Committee (IKDC) Form
The IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.
24 month period
Study Arms (2)
ACL reconstruction control
ACTIVE COMPARATORThe intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL Biocleanse, surgical
EXPERIMENTALThe intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Interventions
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Eligibility Criteria
You may qualify if:
- ACL reconstruction
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UF Orthopedics and Sports Medicine Institute
Gainesville, Florida, 32611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Indelicato, MD
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A. Indelicato, M.D.
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
February 1, 2004
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
March 4, 2014
Results First Posted
March 4, 2014
Record last verified: 2014-01