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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01270919
First received: January 4, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Knee Meniscus Tear
Device: BioDuct Meniscal Repair Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Postoperative compared to preoperative ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BioDuct Meniscal Repair Device
BioDuct Meniscal Repair Device
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.


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270919

Locations
United States, Indiana
Jack Farr, M.D.
Indianapolis, Indiana, United States, 46237
United States, Maryland
Jason Scopp, M.D.
Salisbury, Maryland, United States, 21804
United States, Tennessee
Randall Holcomb
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Stryker Orthopaedics
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01270919     History of Changes
Other Study ID Numbers: 73
Study First Received: January 4, 2011
Results First Received: May 22, 2014
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 30, 2014