Clinical trial NCT03579407: Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis
Official title: Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
cell therapy
stem cells
needle
bone marrow aspiration
Lead sponsor: Advanced Orthopaedic Specialists
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 18-79
* Patients have tried at least 6 weeks of conservative therapy including: activity modification, weight loss, brace, NSAIDs, corticosteroid injection
* Radiographically confirmed Kellgren-Lawrence I-III OA (no bone-on-bone)
* Patients can provide written informed consent

Exclusion Criteria:

* Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiencies
* History of meniscal injury other than degenerative meniscal tears
* Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
* Major mechanical axis deviation of more than 50% into either compartment (varus or valgus)
* Intra-articular injection to affected knee within 3 months of intra-articular BMA injection or HA within 6 months
* Body mass index of 35 or more; 18.5 or less (malnourished)
* Active infection
* Ongoing infectious diseases, including HIV and hepatitis
* Clinically significant diabetes, cardiovascular, hepatic, or renal disease
* Active malignancy, undergoing treatment, has undergone treatment, or has decline treatment
* Use of anti-inflammatory medications, including herbal therapies, within 7 days of BMA
* Use of anti-rheumatic medications, including methotrexate and other antimetabolites, within 3 months prior to study entry
* History of radiation therapy
* History of or current drug or alcohol use disorder
* Current cigarette smokers
* History of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee)
* History of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone)
* Pregnant or currently breast-feeding
* Participation in a study of an experimental drug within 60 days of study entry

Primary outcomes:
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 1 week, 6 weeks, 6 months
Secondary outcomes:
measure: Change in Visual Analog Pain Scale (VAS) of affected knee
timeFrame: Baseline, 1 week, 6 weeks, 6 months
measure: Change in Lysholm Score
timeFrame: Baseline, 1 week, 6 weeks, 6 months
measure: Change in Tegner Score
timeFrame: Baseline, 1 week, 6 weeks, 6 months
measure: Visual Analog Pain Scale (VAS) of aspiration site
timeFrame: Baseline (immediately after intervention), 1 week, 6 weeks, 6 months
Other outcomes:
measure: Cell counts and colony forming units
timeFrame: 1x, immediately after intervention
Locations:
city: Fayetteville
country: United States
facility: Advanced Orthopaedic Specialists
state: Arkansas
Study officials:
affiliation: Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences
name: Ramon Ylanon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: