NCT03579407

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

Terminated NA Last updated 23 July 2021

What this trial tests

NA trial testing BMA cell therapy injection in Osteoarthritis, Knee in 15 participants. Terminated before completion.

Timeline

10 January 2019

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	Advanced Orthopaedic Specialists
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	15
Start date	10 January 2019
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across United States

Drugs / interventions tested

• BMA cell therapy injection

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Advanced Orthopaedic Specialists

Who can join

Adults 18 to 79, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evolution and Innovations in Bone Marrow Cellular Therapy for Musculoskeletal Disorders: Tracing the Historical Trajectory and Contemporary Advances.
   Lana JF, de Brito GC, Kruel A, Brito B, et al · · 2024 · cited 3× · PMID 39451354 · DOI 10.3390/bioengineering11100979