Meniscal TearNCT04775004
Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
A study testing Bone marrow venting procedure (BMVP) and Platelet Rich Plasma (PRP) in people with Meniscal Tear, run by University of Chicago at 3 sites in United States.
Trial summary
There are no current or past RCT comparing biologic augments for meniscal repair. There is good data supporting both the use of BMVP of the intercondylar notch and intra-articular PRP injections for augmentation of meniscal repair. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Meniscal Tear
- What is being tested?
- Bone marrow venting procedure (BMVP) and Platelet Rich Plasma (PRP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jul 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 or older
- Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
- Complex tears may be included at the discretion of the site investigator if patient has one of tear patterns listed in inclusion criteria 2 as the most predominant finding
- No other concomitant procedure unless one of the following:
- Chondroplasty
- Synovectomy
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- Loose body removal
- "Contralateral" menisectomy (i.e. medial meniscus repair with a lateral menisectomy or lateral meniscus repair with a medial menisectomy) would be permitted for inclusion
- Any other procedure that does not include drilling, requires prior approval of the study sponsor for each procedure
Who cannot join
- Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others)
- Patients with meniscus root tears
- Patients undergoing repair for horizontal cleavage tears
- Kellgren-Lawrence scale 3>
- Patients undergoing lateral release
- Ipsilateral chondral lesion with Outerbridge classification of 3-4
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- Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery
- Cortisone use within the six weeks prior to surgery
- Utilizing worker's compensation at the time of screening
- Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus.
- Concomitant ligamentous insufficiency
- Inflammatory rheumatic disease or other rheumatic disease
- Immune compromised patients (hepatitis, HIV, etc.)
- Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc)
- History of distal femur, proximal tibia, or patellar fracture that was treated operatively
- Non English-speaking patients
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago Medicine
Chicago, Illinois, 60637
University of Florida
Gainesville, Florida, 32611
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
There are no current or past RCT comparing biologic augments for meniscal repair. There is good data supporting both the use of BMVP of the intercondylar notch and intra-articular PRP injections for augmentation of meniscal repair. However, the effectiveness of these augmentation methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this particular patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function as well as meniscal repair failure and reoperation rate.
The proposed interventional aim to compare meniscal repair augmentation methods is novel, as the direct comparison of these outcome measures has not been previously described. Because of the known benefit of biologic augmentation of meniscal repair, the investigators hypothesize that the repair failure rate for both cohorts will be lower than the reported repair failure rate for isolated tears without biologic augmentation; the investigators also hypothesize that BMVP of the intercondylar notch will clinically be significantly better than intra-articular PRP injection. The basis behind this hypothesis is in vivo evidence as well as a small RCT supporting the use of BMVP as augmentation for meniscal repair procedures.
- Conditions
- Meniscal Tear
- Being tested
- Bone marrow venting procedure (BMVP), Platelet Rich Plasma (PRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow venting procedure (BMVP)Other
The BMVP involves creating small holes in a non-weight bearing area of the bone that does not have any important structures; the holes act as channels, which allow for flow of the participants own biologic products and stem cells from within the bone marrow.
Platelet Rich Plasma (PRP)Other
The PRP group will have 40cc to 60cc (about 3 tablespoons) of blood drawn at the time of surgery. The blood sample will then be prepared in a centrifuge machine to collect a component of the blood called platelet rich plasma. Once appropriate concentrations of the PRP are confirmed, the PRP will be injected into the subject's knee prior to wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow venting procedure (BMVP) | Active comparator | Subjects randomized in the OR to undergo BMVP surgical augmentation Receives: Other: Bone marrow venting procedure (BMVP) |
| Platelet rich plasma (PRP) | Active comparator | Subjects randomized in the OR to undergo PRP surgical augmentation Receives: Other: Platelet Rich Plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Promis Physical function CAT lower extremity score
Adaptive questionnaire that takes five minutes or less to complete and helps record how subject injury and recovery from surgery is affecting their normal life.
Measured: 1-year after meniscus tear operation.
Secondary outcomes (1)
Re-tear of repair meniscus
Clinically reported (symptomatic) and MRI confirmed via observation of fluid filled tear in the repaired tissue
Measured: 1-year after meniscus tear operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start19 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine
- Responsible party
- Sponsor
- Investigators
- Aravind Athiviraham, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775004
- Sponsor's protocol ID
- IRB20-1394
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
- ClinicalTrials.gov ID
- NCT04775004
- Acronym / sponsor ID
- IRB20-1394
- Conditions
- Meniscal Tear
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are no current or past RCT comparing biologic augments for meniscal repair. There is good data supporting both the use of BMVP of the intercondylar notch and intra-articular PRP injections for augmentation of meniscal repair. However, the effectiveness of these augmentation methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this particular patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function as well as meniscal repair failure and reoperation rate.
The proposed interventional aim to compare meniscal repair augmentation methods is novel, as the direct comparison of these outcome measures has not been previously described. Because of the known benefit of biologic augmentation of meniscal repair, the investigators hypothesize that the repair failure rate for both cohorts will be lower than the reported repair failure rate for isolated tears without biologic augmentation; the investigators also hypothesize that BMVP of the intercondylar notch will clinically be significantly better than intra-articular PRP injection. The basis behind this hypothesis is in vivo evidence as well as a small RCT supporting the use of BMVP as augmentation for meniscal repair procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow venting procedure (BMVP) | Active comparator | Other: Bone marrow venting procedure (BMVP)Subjects randomized in the OR to undergo BMVP surgical augmentation |
| Platelet rich plasma (PRP) | Active comparator | Other: Platelet Rich Plasma (PRP)Subjects randomized in the OR to undergo PRP surgical augmentation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 16 or older
- Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
- Complex tears may be included at the discretion of the site investigator if patient has one of tear patterns listed in inclusion criteria 2 as the most predominant finding
- No other concomitant procedure unless one of the following:
Key exclusion criteria (16 listed)
- Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others)
- Patients with meniscus root tears
- Patients undergoing repair for horizontal cleavage tears
- Kellgren-Lawrence scale 3>
- Patients undergoing lateral release
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 |
|---|---|---|
| Bone marrow venting procedure (BMVP)The BMVP involves creating small holes in a non-weight bearing area of the bone that does not have any important structures; the holes act as channels, which allow for flow of the participants own biologic products and stem cells from within the bone marrow. | Other | Bone marrow venting procedure (BMVP) |
| Platelet Rich Plasma (PRP)The PRP group will have 40cc to 60cc (about 3 tablespoons) of blood drawn at the time of surgery. The blood sample will then be prepared in a centrifuge machine to collect a component of the blood called platelet rich plasma. Once appropriate concentrations of the PRP are confirmed, the PRP will be injected into the subject's knee prior to wound closure. | Other | Platelet rich plasma (PRP) |
Primary outcome
Promis Physical function CAT lower extremity score
Time frame: 1-year after meniscus tear operation.
Adaptive questionnaire that takes five minutes or less to complete and helps record how subject injury and recovery from surgery is affecting their normal life.
1 secondary outcome
Re-tear of repair meniscus
Time frame: 1-year after meniscus tear operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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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.
Aravind Athiviraham, MD principal investigator
University of Chicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow venting procedure (BMVP) and Platelet Rich Plasma (PRP) in people with Meniscal Tear, run by University of Chicago 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 9 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Promis Physical function CAT lower extremity score (time frame: 1-year after meniscus tear operation.). 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 6 Mar 2026.