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

Knee Meniscus Tear Clinical Trial

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.

Status Terminated

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

• Knee Meniscus Tear

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