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

Sponsor

Advanced Orthopaedic Specialists (Other)

Overall Status

Terminated

CT.gov ID

NCT03579407

Collaborator

(none)

Enrollment

Location

Arms

17.7

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 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 :

Jan 10, 2019

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

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.

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

Primary Outcome Measures

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) [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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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