Trial | NCT02285725  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    21
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 Started
Mar 31
2011
Primary Completion
Feb 15
2019
Study Completion
Feb 15
2019
Last Update
Jul 27
2023

Procedure Microdrilling Surgery

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

Procedure Injections of BMAC + PRP + HA

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

Augmented Microdrilling Surgery Experimental

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
No Results Posted