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Clinical Application of BioCleanse Meniscus (Meniscus)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00659880
First Posted: April 16, 2008
Last Update Posted: June 26, 2017
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):
RTI Surgical
Results First Submitted: September 12, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Tear of Meniscus of Knee
Intervention: Other: BioCleanse Meniscus

  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
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Reporting Groups
  Description
Meniscal Allograft Transplant Patients who received a BioCeanse Meniscal Allograft Transplant

Participant Flow:   Overall Study
    Meniscal Allograft Transplant
STARTED   9 
6 Weeks   9 
6 Months   9 
12 Months   7 
24 Months   6 
COMPLETED   4 [1] 
NOT COMPLETED   5 
Lost to Follow-up                5 
[1] 60 months



  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.
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Reporting Groups
  Description
Meniscal Allograft Transplant Patients who received a BioCeanse Meniscal Allograft Transplant

Baseline Measures
   Meniscal Allograft Transplant 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.7  (7.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  33.3% 
Male      6  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures
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1.  Primary:   Knee Injury and Osteoarthritis Outcome Score (KOOS)   [ Time Frame: 60 months ]

2.  Secondary:   MRI Assessments   [ Time Frame: 12 months ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robin Waite, RN
Organization: RTI Surgical
phone: 386-418-8888
e-mail: rwaite@rtix.com



Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT00659880     History of Changes
Other Study ID Numbers: BioMen
First Submitted: April 14, 2008
First Posted: April 16, 2008
Results First Submitted: September 12, 2016
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017