Clinical trial NCT01270919: A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Meniscus Tear
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: Postoperative compared to preoperative
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Jack Farr, M.D.
state: Indiana
city: Salisbury
country: United States
facility: Jason Scopp, M.D.
state: Maryland
city: Memphis
country: United States
facility: Randall Holcomb
state: Tennessee
Study officials:
References: