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

Joseph E. Broyles21 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Microdrilling SurgeryPROCEDURE

All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)

Injections of BMAC + PRP + HAPROCEDURE

All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in International Knee Documentation Committee (IKDC) score

Time frame: Change from baseline at 5 years post-operatively

Secondary Outcomes

Joint Space Changes

Evaluated by plain radiographs

Time frame: 2 and 5 years post-operatively

MRI appearance of repair cartilage

Evaluated using the MOCART scoring system