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

Study Purpose

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.#46; 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 79 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03579407
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Advanced Orthopaedic Specialists
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ramon Ylanon, M.D.
Principal Investigator Affiliation Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Arms & Interventions

Arms

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.

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.

Interventions

Procedure: - BMA cell therapy injection

The bone marrow aspirate will be injected into the affected knee joint.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Advanced Orthopaedic Specialists, Fayetteville, Arkansas

Status

Address

Advanced Orthopaedic Specialists

Fayetteville, Arkansas, 72703

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