Trial Outcomes & Findings for A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device (NCT NCT01270919)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

2 years

Results posted on

2014-06-24

Participant milestones
Measure	BioDuct Meniscal Repair Device BioDuct Meniscal Repair 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.
Overall Study STARTED	0
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline data not reported

Timeframe: 2 years

Outcome data not reported

Timeframe: Postoperative compared to preoperative

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Stryker Orthopedics

Phone: 201-831-5401

Restriction type: OTHER