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

Not Applicable

Completed

• Conditions: Osteoarthritis Knee; Unilateral Primary Osteoarthritis of Knee; Degeneration; Articular Cartilage, Knee; Degenerative Lesion of Articular Cartilage of Knee
• Interventions: Procedure: Microdrilling Surgery; Procedure: Injections of BMAC + PRP + HA

• Registration Number: NCT02285725
• Lead Sponsor: Joseph E. Broyles

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-07
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Augmented Microdrilling Surgery	Injections of BMAC + PRP + HA	-
Augmented Microdrilling Surgery	Microdrilling Surgery	-

Primary Outcome Measures

Name	Time	Method
Change in International Knee Documentation Committee (IKDC) score	Change from baseline at 5 years post-operatively

Secondary Outcome Measures

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