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

NCT01270919 | Terminated Results

• 1 other identifier: 73
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Knee Meniscus Tear

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• 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.

  Postoperative compared to preoperative

Study Arms (1)

BioDuct Meniscal Repair Device

OTHER

BioDuct Meniscal Repair Device

Device: BioDuct Meniscal Repair Device

Interventions

BioDuct Meniscal Repair Device 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.

BioDuct Meniscal Repair Device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (3)

Jack Farr, M.D.

Indianapolis, Indiana, 46237, United States

Location

Jason Scopp, M.D.

Salisbury, Maryland, 21804, United States

Location

Randall Holcomb

Memphis, Tennessee, 38120, United States

Location

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Stryker Orthopedics

ellen.axelson@stryker.com

201-831-5401

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 24, 2014
• Results First Posted: June 24, 2014

Record last verified: 2014-05

Locations

US (3)