Osteoarthritis, KneeNCT03579407
Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis
A study testing BMA cell therapy injection in people with Osteoarthritis, Knee, run by Advanced Orthopaedic Specialists at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- BMA cell therapy injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Advanced Orthopaedic Specialists
Fayetteville, Arkansas, 72703
About this study
Official title: Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
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
- Being tested
- BMA cell therapy injection
- Keywords
- osteoarthritis, cell therapy, stem cells, needle, bone marrow aspiration
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMA cell therapy injectionProcedure or surgery
The bone marrow aspirate will be injected into the affected knee joint.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: BMA cell therapy injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 6 weeks, 6 months
Secondary outcomes (4)
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.
Measured: Baseline, 1 week, 6 weeks, 6 months
Change in Lysholm Score
Will assess for change in Lysholm patient reported outcome score from pre-procedure to post-procedure..
Measured: Baseline, 1 week, 6 weeks, 6 months
Change in Tegner Score
Will assess for change in patient reported activity scale from pre-procedure to post-procedure.
Measured: Baseline, 1 week, 6 weeks, 6 months
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.
Measured: Baseline (immediately after intervention), 1 week, 6 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start10 Jan 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: COVID limitations and staff changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Orthopaedic Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramon Ylanon, M.D., Principal investigator, Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579407
- Sponsor's protocol ID
- bmacneedle
- Status last verified
- Jul 2021
- First submitted
- 21 May 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03579407
- Acronym / sponsor ID
- bmacneedle
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, cell therapy, stem cells, needle, bone marrow aspiration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID limitations and staff changes
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Advanced Orthopaedic SpecialistsUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Open Ended Trocar | Active comparator | Procedure: BMA cell therapy injectionPatients 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. |
| Fenestrated Blunt Trocar | Experimental | Procedure: BMA cell therapy injectionPatients 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMA cell therapy injectionThe bone marrow aspirate will be injected into the affected knee joint. | Procedure or surgery | Fenestrated Blunt Trocar, Traditional Open Ended Trocar |
Primary outcome
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 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.
4 secondary outcomes
Change in Visual Analog Pain Scale (VAS) of affected knee
Time frame: Baseline, 1 week, 6 weeks, 6 months
Change in Lysholm Score
Time frame: Baseline, 1 week, 6 weeks, 6 months
Change in Tegner Score
Time frame: Baseline, 1 week, 6 weeks, 6 months
Visual Analog Pain Scale (VAS) of aspiration site
Time frame: Baseline (immediately after intervention), 1 week, 6 weeks, 6 months
Results and safety
The study was stopped early (reason given: COVID limitations and staff changes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon Ylanon, M.D. principal investigator
Advanced Orthopaedic Specialists and University of Arkansas for Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMA cell therapy injection in people with Osteoarthritis, Knee, run by Advanced Orthopaedic Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID limitations and staff changes). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline, 1 week, 6 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.