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Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:
Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03579407
Study type Interventional
Source Advanced Orthopaedic Specialists
Contact
Status Terminated
Phase N/A
Start date January 10, 2019
Completion date July 1, 2020
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