search
Back to results

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

Primary Purpose

Osteoarthritis, Knee

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BMA cell therapy injection
Sponsored by
Advanced Orthopaedic Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis, Knee focused on measuring osteoarthritis, cell therapy, stem cells, needle, bone marrow aspiration

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Advanced Orthopaedic Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Open Ended Trocar

Fenestrated Blunt Trocar

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Lysholm Score
Will assess for change in Lysholm patient reported outcome score from pre-procedure to post-procedure..
Change in Tegner Score
Will assess for change in patient reported activity scale from pre-procedure to post-procedure.
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.

Full Information

First Posted
May 21, 2018
Last Updated
July 19, 2021
Sponsor
Advanced Orthopaedic Specialists
search

1. Study Identification

Unique Protocol Identification Number
NCT03579407
Brief Title
Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis
Official Title
Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID limitations and staff changes
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Orthopaedic Specialists

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, cell therapy, stem cells, needle, bone marrow aspiration

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Open Ended Trocar
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fenestrated Blunt Trocar
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
BMA cell therapy injection
Intervention Description
The bone marrow aspirate will be injected into the affected knee joint.
Primary Outcome Measure Information:
Title
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
Baseline, 1 week, 6 weeks, 6 months
Secondary Outcome Measure Information:
Title
Change in Visual Analog Pain Scale (VAS) of affected knee
Description
Will assess for change in patient reported pain scale of the patient's affected/treated knee from pre-procedure to post-procedure.
Time Frame
Baseline, 1 week, 6 weeks, 6 months
Title
Change in Lysholm Score
Description
Will assess for change in Lysholm patient reported outcome score from pre-procedure to post-procedure..
Time Frame
Baseline, 1 week, 6 weeks, 6 months
Title
Change in Tegner Score
Description
Will assess for change in patient reported activity scale from pre-procedure to post-procedure.
Time Frame
Baseline, 1 week, 6 weeks, 6 months
Title
Visual Analog Pain Scale (VAS) of aspiration site
Description
Will assess the patient reported pain scale of the patient's aspiration site immediately after intervention and changes at the various time points.
Time Frame
Baseline (immediately after intervention), 1 week, 6 weeks, 6 months
Other Pre-specified Outcome Measures:
Title
Cell counts and colony forming units
Description
For each aspiration in the study, total nucleated cell counts and colony forming units will be analyzed.
Time Frame
1x, immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Ylanon, M.D.
Organizational Affiliation
Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Orthopaedic Specialists
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs