A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01270919
First received: January 4, 2011
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: May 22, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Knee Meniscus Tear
Intervention: Device: BioDuct Meniscal Repair Device

  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
BioDuct Meniscal Repair Device

BioDuct Meniscal Repair Device

BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.

The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear.


Participant Flow:   Overall Study
    BioDuct Meniscal Repair Device  
STARTED     0 [1]
COMPLETED     0  
NOT COMPLETED     0  
[1] One participant was enrolled but was censored.



  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
BioDuct Meniscal Repair Device

BioDuct Meniscal Repair Device

BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.

The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear.


Baseline Measures
    BioDuct Meniscal Repair Device  
Number of Participants  
[units: participants]
  0  
Age  
[units: years]
Mean ± Standard Deviation
   
Gender  
[units: participants]
 
Female      
Male      
Region of Enrollment  
[units: participants]
 
United States      



  Outcome Measures
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1.  Primary:   To Demonstrate Repair of the Meniscus 6 Months Post-implantation of the BioDuct® Meniscal Repair Device, Utilizing MRI. To Evaluate Clinical Success Using Postoperative Qualitative Criteria, as Compared to Preoperative Findings.   [ Time Frame: 2 years ]

2.  Secondary:   To Evaluate the Change in Outcomes From the Preoperative Time Point to Postoperative Time Points in Cases Implanted With the BioDuct® Meniscal Repair Device Using the SF-12, VAS Pain, WOMET and IKDC Subjective Knee Evaluation.   [ Time Frame: Postoperative compared to preoperative ]


  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: Director of Clinical Research
Organization: Stryker Orthopedics
phone: 201-831-5401
e-mail: ellen.axelson@stryker.com


No publications provided


Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01270919     History of Changes
Other Study ID Numbers: 73
Study First Received: January 4, 2011
Results First Received: May 22, 2014
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration