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

Joseph E. Broyles0 sites21 target enrollmentMarch 2011

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Unilateral Primary Osteoarthritis of Knee
Sponsor: Joseph E. Broyles
Enrollment: 21
Primary Endpoint: Change in International Knee Documentation Committee (IKDC) score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

February 15, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Joseph E. Broyles

Responsible Party

Sponsor Investigator

Principal Investigator

Joseph E. Broyles

Joseph E. Broyles, M.D.

Bone and Joint Clinic of Baton Rouge

Eligibility 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

Outcomes

Primary Outcomes

Change in International Knee Documentation Committee (IKDC) score

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

Secondary Outcomes

MRI appearance of repair cartilage(2 and 5 years post-operatively)
Joint Space Changes(2 and 5 years post-operatively)
Frequency of adverse events requiring additional procedures(Continuously for 5 years post-operatively)