Status:
COMPLETED
Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
Lead Sponsor:
Joseph E. Broyles
Conditions:
Unilateral Primary Osteoarthritis of Knee
Osteoarthritis Knee
Eligibility:
All Genders
18-64 years
Phase:
NA
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 in...
Eligibility Criteria
Inclusion
- MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02285725
Start Date
March 1 2011
End Date
February 15 2019
Last Update
July 27 2023
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