Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)

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 Overview

• Status: Recruiting
• Conditions: Meniscal Tear
• Intervention / Treatment: Other: Bone marrow venting procedure (BMVP); Other: Platelet Rich Plasma (PRP)

• Study Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida
      • Contact: Marissa Pazik, MS; Email: pazikmn@ortho.ufl.edu
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine
      • Contact: Justin Bell; Phone Number: 773-834-0822
      • Principal Investigator: Aravind Athiviraham, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Erica Hartzell, MS; Email: ehartzel@wakehealth.edu
      • Contact: Nina Cruz-Diaz; Email: nmcruzdi@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bone marrow venting procedure (BMVP); Subjects randomized in the OR to undergo BMVP surgical augmentation	Other: 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.
Active Comparator: Platelet rich plasma (PRP); Subjects randomized in the OR to undergo PRP surgical augmentation	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-year after meniscus tear operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-tear of repair meniscus	Clinically reported (symptomatic) and MRI confirmed via observation of fluid filled tear in the repaired tissue	1-year after meniscus tear operation.

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: American Orthopaedic Society for Sports Medicine
• Investigators: Principal Investigator: Aravind Athiviraham, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB20-1394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No