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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02285725
Recruitment Status : Active, not recruiting
First Posted : November 7, 2014
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Joseph E. Broyles, Bone and Joint Clinic of Baton Rouge

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).

Condition or disease Intervention/treatment Phase
Unilateral Primary Osteoarthritis of Knee Osteoarthritis Knee Degeneration; Articular Cartilage, Knee Degenerative Lesion of Articular Cartilage of Knee Procedure: Microdrilling Surgery Biological: Injections of BMAC + PRP + HA Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Augmented Microdrilling Surgery 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)

Biological: Injections of BMAC + PRP + HA
All patients will receive up to 12 post-operative intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA (Supartz)

Primary Outcome Measures :
  1. Change in International Knee Documentation Committee (IKDC) score [ Time Frame: Change from baseline at 5 years post-operatively ]

Secondary Outcome Measures :
  1. Joint Space Changes [ Time Frame: 2 and 5 years post-operatively ]
    Evaluated by plain radiographs

  2. MRI appearance of repair cartilage [ Time Frame: 2 and 5 years post-operatively ]
    Evaluated using the MOCART scoring system

  3. Frequency of adverse events requiring additional procedures [ Time Frame: Continuously for 5 years post-operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Additional Information:
Responsible Party: Joseph E. Broyles, Joseph E. Broyles, M.D., Bone and Joint Clinic of Baton Rouge Identifier: NCT02285725     History of Changes
Other Study ID Numbers: BMPRP1001
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases