Knee Meniscus TearNCT01270919
A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device
A study testing BioDuct Meniscal Repair Device in people with Knee Meniscus Tear, run by Stryker Orthopaedics at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Knee Meniscus Tear
- What is being tested?
- BioDuct Meniscal Repair Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jack Farr, M.D.
Indianapolis, Indiana, 46237
Randall Holcomb
Memphis, Tennessee, 38120
Jason Scopp, M.D.
Salisbury, Maryland, 21804
About this study
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.
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.
Read the 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.
- Conditions
- Knee Meniscus Tear
- Being tested
- BioDuct Meniscal Repair Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioDuct Meniscal Repair DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BioDuct Meniscal Repair Device | Other | BioDuct Meniscal Repair Device Receives: Device: BioDuct Meniscal Repair Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative compared to preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee Meniscus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270919
- Sponsor's protocol ID
- 73
- Status last verified
- May 2014
- First submitted
- 4 Jan 2011
- Last updated
- 24 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01270919
- Acronym / sponsor ID
- 73
- Conditions
- Knee Meniscus Tear
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 24 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioDuct Meniscal Repair Device | Other | Device: BioDuct Meniscal Repair DeviceBioDuct Meniscal Repair Device |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioDuct Meniscal Repair DeviceThe 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. | Device | BioDuct Meniscal Repair Device |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioDuct Meniscal Repair Device in people with Knee Meniscus Tear, run by Stryker Orthopaedics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014; AzTrials last refreshed its copy on 6 Nov 2026.