Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated… (NCT02285725) | Clinical Trial Compass
CompletedNot Applicable
Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
21 participantsStarted 2011-03
Plain-language 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).
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in International Knee Documentation Committee (IKDC) score
Timeframe: Change from baseline at 5 years post-operatively