Osteoarthritis Knee Clinical Trial
NCT number | NCT02285725 |
Other study ID # | BMPRP1001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2011 |
Est. completion date | February 15, 2019 |
Verified date | July 2023 |
Source | Bone and Joint Clinic of Baton Rouge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 21 |
Est. completion date | February 15, 2019 |
Est. primary completion date | February 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Joseph E. Broyles |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in International Knee Documentation Committee (IKDC) score | Change from baseline at 5 years post-operatively | ||
Secondary | Joint Space Changes | Evaluated by plain radiographs | 2 and 5 years post-operatively | |
Secondary | MRI appearance of repair cartilage | Evaluated using the MOCART scoring system | 2 and 5 years post-operatively | |
Secondary | Frequency of adverse events requiring additional procedures | Continuously for 5 years post-operatively |
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