Osteoarthritis (OA) is a leading cause of disability around the world. The aging population is only further increasing its prevalence. Moreover, increasing rates of obesity, as well as increasing athletic participation, is leading to patients developing OA at younger ages. Although total joint replacement is effective for alleviating the effects of OA for many patients, it is less beneficial for younger patients given the resultant reduced mobility and the \~15 year life of a total joint replacement. Therefore, new options are needed for OA. One such option is bone marrow aspirate concentrate (BMAC) injection into the diseased joint. Several recent studies have shown significant symptomatic improvement from this therapy. Now, efforts are needed to better understand how to optimize this therapy, as numerous variables are involved, including: the volume of aspirate, adjuvant, aspiration location or locations, anesthetic, etc. Additionally, several FDA-approved needles are available for the aspiration step. Thus, the purpose of this study is to compare two different styles of FDA-approved needles--an open-ended trocar vs. a fenestrated blunt trocar--with respect to clinical outcomes, cell counts, and colony forming units. In addition to the comparison arms, taking these two groups together, this study will serve as prospective case series of 30 patients undergoing BMAC injection for knee osteoarthritis without a platelet-rich plasma (PRP) or any other adjuvant/carrier.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
15
The bone marrow aspirate will be injected into the affected knee joint.
Advanced Orthopaedic Specialists
Fayetteville, Arkansas, United States
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Will assess for change in patient reported outcome measure that assesses symptoms, stiffness, pain, function, and quality of life from pre-procedure to post-procedure.
Time frame: Baseline, 1 week, 6 weeks, 6 months
Change in Visual Analog Pain Scale (VAS) of affected knee
Will assess for change in patient reported pain scale of the patient's affected/treated knee from pre-procedure to post-procedure.
Time frame: Baseline, 1 week, 6 weeks, 6 months
Change in Lysholm Score
Will assess for change in Lysholm patient reported outcome score from pre-procedure to post-procedure..
Time frame: Baseline, 1 week, 6 weeks, 6 months
Change in Tegner Score
Will assess for change in patient reported activity scale from pre-procedure to post-procedure.
Time frame: Baseline, 1 week, 6 weeks, 6 months
Visual Analog Pain Scale (VAS) of aspiration site
Will assess the patient reported pain scale of the patient's aspiration site immediately after intervention and changes at the various time points.
Time frame: Baseline (immediately after intervention), 1 week, 6 weeks, 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.