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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

Tracking Information
First Submitted Date  ICMJE May 21, 2018
First Posted Date  ICMJE July 6, 2018
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE January 10, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 1 month, 3 months, 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.
Change History Complete list of historical versions of study NCT03579407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
  • 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.
  • 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..
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
  • Change in Visual Analog Pain Scale (VAS) of affected knee [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    Will assess for change in patient reported pain scale of the patient's affected/treated knee from pre-procedure to post-procedure.
  • Change in Lysholm Score [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    Will assess for change in Lysholm patient reported outcome score from pre-procedure to post-procedure..
  • Change in Tegner Score [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    Will assess for change in patient reported activity scale from pre-procedure to post-procedure.
  • Visual Analog Pain Scale (VAS) of aspiration site [ Time Frame: Baseline (immediately after intervention), 1 month, 3 months, 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.
Current Other Pre-specified Outcome Measures
 (submitted: June 25, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis
Official Title  ICMJE Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Procedure: BMA cell therapy injection
The bone marrow aspirate will be injected into the affected knee joint.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: BMA cell therapy injection
  • 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.
    Intervention: Procedure: BMA cell therapy injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 25, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03579407
Other Study ID Numbers  ICMJE bmacneedle
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Advanced Orthopaedic Specialists
Study Sponsor  ICMJE Advanced Orthopaedic Specialists
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ramon Ylanon, M.D. Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences
PRS Account Advanced Orthopaedic Specialists
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP