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

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ClinicalTrials.gov Identifier: NCT03579407
Recruitment Status : Enrolling by invitation
First Posted : July 6, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Advanced Orthopaedic Specialists

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: BMA cell therapy injection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 1 week, 6 weeks, 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in Visual Analog Pain Scale (VAS) of affected knee [ Time Frame: Baseline, 1 week, 6 weeks, 6 months ]
    Will assess for change in patient reported pain scale of the patient's affected/treated knee from pre-procedure to post-procedure.

  2. Change in Lysholm Score [ Time Frame: Baseline, 1 week, 6 weeks, 6 months ]
    Will assess for change in Lysholm patient reported outcome score from pre-procedure to post-procedure..

  3. Change in Tegner Score [ Time Frame: Baseline, 1 week, 6 weeks, 6 months ]
    Will assess for change in patient reported activity scale from pre-procedure to post-procedure.

  4. Visual Analog Pain Scale (VAS) of aspiration site [ Time Frame: Baseline (immediately after intervention), 1 week, 6 weeks, 6 months ]
    Will assess the patient reported pain scale of the patient's aspiration site immediately after intervention and changes at the various time points.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579407


Locations
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United States, Arkansas
Advanced Orthopaedic Specialists
Fayetteville, Arkansas, United States, 72703
Sponsors and Collaborators
Advanced Orthopaedic Specialists
Investigators
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Principal Investigator: Ramon Ylanon, M.D. Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences
More Information
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Responsible Party: Advanced Orthopaedic Specialists
ClinicalTrials.gov Identifier: NCT03579407     History of Changes
Other Study ID Numbers: bmacneedle
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Advanced Orthopaedic Specialists:
osteoarthritis
cell therapy
stem cells
needle
bone marrow aspiration

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases