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Evaluation of Biocleanse Allografts For ACL Reconstruction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187876
First Posted: September 16, 2005
Last Update Posted: March 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
Results First Submitted: December 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Anterior Cruciate Ligament Tear
Interventions: Procedure: ACL reconstruction control
Procedure: ACL Biocleanse, surgical

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ACL Reconstruction Control

The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.

ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that are non- irradiated aseptically, processed BTB allografts.

ACL Biocleanse, Surgical

The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.

ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.


Participant Flow:   Overall Study
    ACL Reconstruction Control   ACL Biocleanse, Surgical
STARTED   24   43 
COMPLETED   24   43 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ACL Reconstruction Control

The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.

ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts.

ACL Biocleanse, Surgical

The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.

ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.

Total Total of all reporting groups

Baseline Measures
   ACL Reconstruction Control   ACL Biocleanse, Surgical   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   43   67 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.3  (9.2)   35.6  (8.9)   33.5  (9.05) 
Gender 
[Units: Participants]
     
Female   8   18   26 
Male   16   25   41 
Region of Enrollment 
[Units: Participants]
     
United States   24   43   67 


  Outcome Measures

1.  Primary:   International Knee Documentation Committee (IKDC) Form   [ Time Frame: 24 month period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Indelicato, MD
Organization: University of Florida
phone: 352-273-7017
e-mail: wernegs@ortho.ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00187876     History of Changes
Other Study ID Numbers: 566-2003
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: December 4, 2013
Results First Posted: March 4, 2014
Last Update Posted: March 4, 2014