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

Primary Purpose

Unilateral Primary Osteoarthritis of Knee, Osteoarthritis Knee, Degeneration; Articular Cartilage, Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microdrilling Surgery
Injections of BMAC + PRP + HA
Sponsored by
Joseph E. Broyles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Primary Osteoarthritis of Knee

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Augmented Microdrilling Surgery

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in International Knee Documentation Committee (IKDC) score

    Secondary Outcome Measures

    Joint Space Changes
    Evaluated by plain radiographs
    MRI appearance of repair cartilage
    Evaluated using the MOCART scoring system
    Frequency of adverse events requiring additional procedures

    Full Information

    First Posted
    October 31, 2014
    Last Updated
    July 25, 2023
    Sponsor
    Joseph E. Broyles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02285725
    Brief Title
    Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (Actual)
    Primary Completion Date
    February 15, 2019 (Actual)
    Study Completion Date
    February 15, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Joseph E. Broyles

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unilateral Primary Osteoarthritis of Knee, Osteoarthritis Knee, Degeneration; Articular Cartilage, Knee, Degenerative Lesion of Articular Cartilage of Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Augmented Microdrilling Surgery
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Microdrilling Surgery
    Intervention Description
    All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
    Intervention Type
    Procedure
    Intervention Name(s)
    Injections of BMAC + PRP + HA
    Intervention Description
    All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA
    Primary Outcome Measure Information:
    Title
    Change in International Knee Documentation Committee (IKDC) score
    Time Frame
    Change from baseline at 5 years post-operatively
    Secondary Outcome Measure Information:
    Title
    Joint Space Changes
    Description
    Evaluated by plain radiographs
    Time Frame
    2 and 5 years post-operatively
    Title
    MRI appearance of repair cartilage
    Description
    Evaluated using the MOCART scoring system
    Time Frame
    2 and 5 years post-operatively
    Title
    Frequency of adverse events requiring additional procedures
    Time Frame
    Continuously for 5 years post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    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 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

    12. IPD Sharing Statement

    Links:
    URL
    http://cartilageregenerationcenter.com
    Description
    Related Info

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

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