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

Stopped early · Not applicable

Conditions studied: Knee Meniscus Tear

In brief

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.

Key facts

Study ID

NCT01270919

Run by

Stryker Orthopaedics

People needed

1

Starts

2010-11-01

Expected to finish

2011-05-01

Last updated by the study team

2014-06-24

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
• B. Patient is a male or non-pregnant female age 45 years or younger at time of study device implantation.
• C. Patient is a candidate for repair of one longitudinal vertical tear (bucket handle) fully located in the red-white (vascular-avascular) zone of the meniscus (3-5 mm from the synovial-meniscus junction) or repair of one longitudinal vertical tear (bucket handle) primarily located in the red-white zone of the meniscus, but partially (< 30% of total length) extending into the red zone (< 3 mm from the synovial-meniscus junction) and/or into the white zone (> 5 mm from the synovial-meniscus junction).
• D. Patient does not require more than three BioDuct® Meniscal Repair Devices for the meniscal tear.
• E. Patient requires suture only for fixation at the site where the study device will be used.
• F. Patient is willing and able to comply with postoperative scheduled MRI and clinical evaluations and rehabilitation.

You may not qualify if…

• G. Patient has a Body Mass Index (BMI) > 35.
• H. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
• I. Patient has horizontal, transverse, degenerative complex tears.
• J. Patient has ACL and/or PCL deficiencies within the operative knee and is not undergoing concomitant repair of these deficiencies.
• K. Patient requires bilateral meniscal repair.
• L. Patient requires meniscectomy.
• M. Patient presents with abnormal degenerative osteoarthritis of the joint [e.g. International Cartilage Repair Society (ICRS) Grade III or higher and/or Modified Outerbridge Grade III or higher].
• N. Patient has undergone previous meniscal repair to the operative knee.
• O. Patient has a knee joint with greater than 5º anatomic axis misalignment.
• P. Patient has active synovitis.
• Q. Patient is a prisoner.

Where it is running

• Jack Farr, M.D. — Indianapolis, Indiana, United States
• Jason Scopp, M.D. — Salisbury, Maryland, United States
• Randall Holcomb — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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