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

Joseph E. Broyles

Status

Completed

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Unilateral Primary Osteoarthritis of Knee

Degeneration; Articular Cartilage, Knee

Osteoarthritis Knee

Treatments

Procedure: Microdrilling Surgery

Procedure: Injections of BMAC + PRP + HA

Study type

Interventional

Funder types

Other

Identifiers

NCT02285725

BMPRP1001

Details and patient eligibility

About

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).

Enrollment

21 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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