A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device
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|ClinicalTrials.gov Identifier: NCT01270919|
Recruitment Status : Terminated
First Posted : January 5, 2011
Results First Posted : June 24, 2014
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Knee Meniscus Tear||Device: BioDuct Meniscal Repair Device||Not Applicable|
To demonstrate repair of the meniscus 6 months postimplantation of the BioDuct® Meniscal Repair Device, utilizing MRI.
To evaluate clinical success by comparing the following qualitative criteria at 2 years postoperative to preoperative findings: effusion, swelling, pain, catching, locking, focal joint line pain and mechanical symptoms, if present preoperative. Clinical success is defined as no worsening for any of these criteria and improvement in at least one of these criteria.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||This Study Will be a Prospective, Non-randomized Evaluation of the Change Between Preoperative and Postoperative Outcomes for Those Who Receive the BioDuct® Device Meniscal Repair Device.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
BioDuct Meniscal Repair Device
BioDuct Meniscal Repair Device
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270919
|United States, Indiana|
|Jack Farr, M.D.|
|Indianapolis, Indiana, United States, 46237|
|United States, Maryland|
|Jason Scopp, M.D.|
|Salisbury, Maryland, United States, 21804|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38120|