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

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

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 Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: BMA cell therapy injection

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Advanced Orthopaedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Open Ended Trocar; 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; The bone marrow aspirate will be injected into the affected knee joint.
Experimental: Fenestrated Blunt Trocar; 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; The bone marrow aspirate will be injected into the affected knee joint.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell counts and colony forming units	For each aspiration in the study, total nucleated cell counts and colony forming units will be analyzed.	1x, immediately after intervention

Collaborators and Investigators

• Sponsor: Advanced Orthopaedic Specialists
• Investigators: Principal Investigator: Ramon Ylanon, M.D., Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; stem cells; cell therapy; needle; bone marrow aspiration
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: bmacneedle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No