A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device
To demonstrate repair of the meniscus at 6 months, as evaluated by MRI, will be observed; and clinical qualitative assessments will improve from preoperative to postoperative time points with the BioDuct® Meniscal Repair Device.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: 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 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.
|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|