We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285725
First Posted: November 7, 2014
Last Update Posted: March 17, 2016
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.
Information provided by (Responsible Party):
Joseph E. Broyles, Bone and Joint Clinic of Baton Rouge
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Joseph E. Broyles, Bone and Joint Clinic of Baton Rouge:

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

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

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

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

Enrollment: 21
Study Start Date: March 2011
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Joseph E. Broyles, Joseph E. Broyles, M.D., Bone and Joint Clinic of Baton Rouge
ClinicalTrials.gov Identifier: NCT02285725     History of Changes
Other Study ID Numbers: BMPRP1001
First Submitted: October 31, 2014
First Posted: November 7, 2014
Last Update Posted: March 17, 2016
Last Verified: March 2016

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