Degeneration; Articular Cartilage, Knee, Degenerative Lesion of Articular Cartilage of Knee, Osteoarthritis Knee, Unilateral Primary Osteoarthritis of Knee
Conditions
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).
Interventions
PROCEDUREMicrodrilling Surgery
All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
PROCEDUREInjections of BMAC + PRP + HA
All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA
Sponsors
Joseph E. Broyles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in International Knee Documentation Committee (IKDC) score | Change from baseline at 5 years post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Joint Space Changes | 2 and 5 years post-operatively | Evaluated by plain radiographs |
| MRI appearance of repair cartilage | 2 and 5 years post-operatively | Evaluated using the MOCART scoring system |
| Frequency of adverse events requiring additional procedures | Continuously for 5 years post-operatively | — |
Outcome results
None listed