Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid

Study Overview
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Brief Summary
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This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).

Conditions
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Unilateral Primary Osteoarthritis of Knee, Osteoarthritis Knee, Degeneration; Articular Cartilage, Knee, Degenerative Lesion of Articular Cartilage of Knee

Intervention / Treatment
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* Procedure: Microdrilling Surgery
* Procedure: Injections of BMAC + PRP + HA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis. Exclusion Criteria: Inflammatory arthritis Body mass index (BMI) greater than 35 Presence of significant varus or valgus knee instability or unusually stiff knee Greater than 50% deviation of the mechanical axis Presence of active cardiac disease Presence of active pulmonary disease Prior septic arthritis of the involved joint Presence of active bacterial or Mycobacterial infection Presence of a known hypercoagulable state Pregnant or lactating females Subject known to be positive for hepatitis B, hepatitis C, or HIV Known allergy to hyaluronic acid Patients who are unable or unwilling to participate fully in post-operative physical therapy Patients with a contraindication to MRI scanning Any disorder that compromises ability to give consent or comply with study procedures Patients who are felt to be at significantly increased risk for elective orthopedic surgery Non-ambulatory patients Patients with cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Microdrilling Surgery<br> | Procedure: Microdrilling Surgery<br>* All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)<br>Procedure: Injections of BMAC + PRP + HA<br>* All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Knee Documentation Committee (IKDC) score |  | Change from baseline at 5 years post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint Space Changes | Evaluated by plain radiographs | 2 and 5 years post-operatively | 
| MRI appearance of repair cartilage | Evaluated using the MOCART scoring system | 2 and 5 years post-operatively | 
| Frequency of adverse events requiring additional procedures |  | Continuously for 5 years post-operatively |