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

NCT03579407 | Terminated FDA Device

• 1 other identifier: bmacneedle
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; cell therapy; stem cells; needle; bone marrow aspiration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Visual Analog Pain Scale (VAS) of affected knee

  Baseline, 1 week, 6 weeks, 6 months

• Change in Lysholm Score

  Baseline, 1 week, 6 weeks, 6 months

• Change in Tegner Score

  Baseline, 1 week, 6 weeks, 6 months

• Visual Analog Pain Scale (VAS) of aspiration site

  Baseline (immediately after intervention), 1 week, 6 weeks, 6 months

Other Outcomes (1)

• Cell counts and colony forming units

  1x, immediately after intervention

Study Arms (2)

Traditional Open Ended Trocar

ACTIVE COMPARATOR

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

Fenestrated Blunt Trocar

EXPERIMENTAL

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

Interventions

BMA cell therapy injection PROCEDURE

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

Fenestrated Blunt Trocar; Traditional Open Ended Trocar

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Orthopaedic Specialists: lead

Study Sites (1)

Advanced Orthopaedic Specialists

Fayetteville, Arkansas, 72703, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ramon Ylanon, M.D.

  Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: July 6, 2018
• Study Start: January 10, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)