Clinical trial NCT04775004: Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
Official title: Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscal Tear
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: American Orthopaedic Society for Sports Medicine
First posted: 2021-03-01
Enrollment: 146
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria

1. Age 16 or older
2. Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
3. 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
4. No other concomitant procedure unless one of the following:

   * Chondroplasty
   * Synovectomy
   * 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

Exclusion Criteria

1. Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others)
2. Patients with meniscus root tears
3. Patients undergoing repair for horizontal cleavage tears
4. Kellgren-Lawrence scale 3\>
5. Patients undergoing lateral release
6. Ipsilateral chondral lesion with Outerbridge classification of 3-4
7. Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery
8. Cortisone use within the six weeks prior to surgery
9. Utilizing worker's compensation at the time of screening
10. Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus.
11. Concomitant ligamentous insufficiency
12. Inflammatory rheumatic disease or other rheumatic disease
13. Immune compromised patients (hepatitis, HIV, etc.)
14. Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc)
15. History of distal femur, proximal tibia, or patellar fracture that was treated operatively
16. Non English-speaking patients

Primary outcomes:
measure: Promis Physical function CAT lower extremity score
timeFrame: 1-year after meniscus tear operation.
Secondary outcomes:
measure: Re-tear of repair meniscus
timeFrame: 1-year after meniscus tear operation.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: University of Chicago
name: Aravind Athiviraham, MD
role: PRINCIPAL_INVESTIGATOR
References: