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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01270919
Study type Interventional
Source Stryker Orthopaedics
Contact
Status Terminated
Phase N/A
Start date November 2010
Completion date May 2011

See also
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