Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
1 other identifier
interventional
21
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2019
CompletedJuly 27, 2023
July 1, 2023
8 years
October 31, 2014
July 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in International Knee Documentation Committee (IKDC) score
Change from baseline at 5 years post-operatively
Secondary Outcomes (3)
Joint Space Changes
2 and 5 years post-operatively
MRI appearance of repair cartilage
2 and 5 years post-operatively
Frequency of adverse events requiring additional procedures
Continuously for 5 years post-operatively
Study Arms (1)
Augmented Microdrilling Surgery
EXPERIMENTALInterventions
All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA
Eligibility Criteria
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Joseph E. Broyles, M.D.
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 7, 2014
Study Start
March 1, 2011
Primary Completion
February 15, 2019
Study Completion
February 15, 2019
Last Updated
July 27, 2023
Record last verified: 2023-07