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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03579407
• Other study ID #: bmacneedle
• Status: Terminated
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2021
• Source: Advanced Orthopaedic Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• BMA cell therapy injection
The bone marrow aspirate will be injected into the affected knee joint.

Locations

Country	Name	City	State
United States	Advanced Orthopaedic Specialists	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Orthopaedic Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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