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OpenTrials
Completed

NCT Number: NCT02285725

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

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).

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Key information

Conditions

Unilateral Primary Osteoarthritis of Knee Arthritis Degeneration; Articular Cartilage, Knee Degenerative Lesion of Articular Cartilage of Knee Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis Knee Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microdrilling Surgery

Procedure

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

Injections of BMAC + PRP + HA

Procedure

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 outcomes

  1. Change in International Knee Documentation Committee (IKDC) score

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Joseph E. Broyles

Other

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2014
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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