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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: BMA cell therapy injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Open Ended Trocar<br>Patients will undergo bone marrow aspiration using the Jamshidi bone marrow aspiration needle. This needle is the traditional trocar with an open end. 50-60 mL will be collected and concentrated with a centrifuge. | Procedure: BMA cell therapy injection<br>* The bone marrow aspirate will be injected into the affected knee joint.<br>|
| Experimental: Fenestrated Blunt Trocar<br>Patients will undergo bone marrow aspiration using the Marrow Cellution bone marrow aspiration needle. This needle has several fenestrations along the trocar through which the bone marrow is aspirated. Approximately 8-10 mL of high concentrate bone marrow will be collected, which will not be concentrated. | Procedure: BMA cell therapy injection<br>* The bone marrow aspirate will be injected into the affected knee joint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1 week, 6 weeks, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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.. | 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. | 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. | Baseline (immediately after intervention), 1 week, 6 weeks, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, cell therapy, needle, bone marrow aspiration, stem cells