Knee OsteoarthritisPhase 3NCT06238934

Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial

A Phase 3 study testing Bone marrow aspirate matrix, Bone marrow aspirate and Hyaluronic acid in people with Knee Osteoarthritis, run by Instituto Nacional de Traumatologia e Ortopedia at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 40 to 60 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Bone marrow aspirate matrix, Bone marrow aspirate and Hyaluronic acid
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteBrazil
Study dates: Mar 2024to Mar 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 40 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Bilateral knee OA according to the American College of Rheumatology criteria Kellgren-Lawrence ≤ III in both knees Full range of movement (0 a 120°).

Who cannot join

1) history of trauma, infection or previous surgery in the affected limb two years before procedure (2)limb malalignment: varus> 10° or valgus >15° (3) corticosteroids 3 months before the procedure (4) viscosupplementation 12 months before procedure (5) inflammatory, rheumatological or autoimmune disease (6) body mass index >35 kg/m2 (7) use of immunosuppresors or anticoagulants (8) active tumor (9) haematological disorder (10) Hip OA > Tonnis grade 3 (11) history of transmissible disease (12) patients unable for positioning for the procedure (13) patients living outside Rio de Janeiro metropolitan area

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site

Instituto Nacional de Traumatologia e Ortopedia
Rio de Janeiro, Rio de Janeiro, 20940-070
Eduardo B de Sousa, MD, PhD, 21998913144, eduardobranco.joelho@gmail.com
Phelippe Augusto V Maia, MD, MSC

Other trials in Brazil

About this study

Knee osteoarthritis (KOA) first manifests itself as a molecular derangement followed by anatomical and/or physiological changes. Conservative treatment of osteoarthritis should be the first approach to patients with this disease. The interest in biological therapies, including viscosupplementation and cell therapy, involves the recent update in knowledge about the pathophysiology of OA and its natural history. The aim of the present study is to compare the clinical results of intra-articular hyaluronic acid infiltration (IHA), bone marrow aspirate (BMA) and BMA matrix in the treatment of knee osteoarthritis. The sample will consist of 90 patients with osteoarthritis of the knee followed up at the INTO, who will be divided into three groups: group A, treatment with BMA; group B, treatment with IHA ; and group C, treatment with BMA matrix. Patients will be submitted to clinical, subjective functional and radiographic evaluation by an observer independent of the one who applied the selected treatment, at moments before application and 3 months, 6 months and 12 months after application. We believe that treatment with BMA and the BMA matrix have a better effect in improving symptoms and for a longer period of time than treatment with hyaluronic acid.

Conditions: Knee Osteoarthritis
Being tested: Bone marrow aspirate matrix, Bone marrow aspirate, Hyaluronic acid
Keywords: osteoarthritis, knee, hyaluronic acid, bone marrow aspirate, bone marrow aspirate matrix
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.

Bone marrow aspirate matrixBiological
Bone marrow aspirate * Hyaluronic acid
Bone marrow aspirateBiological
Bone marrow aspirate
Hyaluronic acidDevice
Hyaluronic acid

Study groups in NCT06238934
Study group	Role	What they receive
Group A	Experimental	Bone marrow aspirate matrix Receives: Biological: Bone marrow aspirate matrix
Group B	Active comparator	Bone marrow aspirate Receives: Biological: Bone marrow aspirate
Group C	Active comparator	Hyaluronic acid Receives: Device: Hyaluronic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Knee Society Score
Measured: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
Western Ontario and Mcmaster (WOMAC) score
Measured: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
Visual analog scale for pain
Measured: before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2024Mar 2027

First posted2 Feb 2024
Study startMar 2024 (estimated)
Primary completionMar 2025 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee OsteoarthritisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06238934
Sponsor's protocol ID: 74952423.1.0000.5273
Status last verified: Jan 2024
First submitted: 26 Jan 2024
Last updated: 2 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial
ClinicalTrials.gov ID: NCT06238934
Acronym / sponsor ID: 74952423.1.0000.5273
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis, knee, hyaluronic acid, bone marrow aspirate, bone marrow aspirate matrix
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 90 participants (estimated)
Lead sponsor: Instituto Nacional de Traumatologia e OrtopediaOther government
Study start: Mar 2024 (estimated)
Primary completion: Mar 2025 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 2 Feb 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: Bone marrow aspirate matrixBone marrow aspirate matrix
Group B	Active comparator	Biological: Bone marrow aspirateBone marrow aspirate
Group C	Active comparator	Device: Hyaluronic acidHyaluronic acid

Who may qualify

Ages: 40 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Bilateral knee OA according to the American College of Rheumatology criteria Kellgren-Lawrence ≤ III in both knees Full range of movement (0 a 120°).

Key exclusion criteria (1 listed)

1) history of trauma, infection or previous surgery in the affected limb two years before procedure (2)limb malalignment: varus> 10° or valgus >15° (3) corticosteroids 3 months before the procedure (4) viscosupplementation 12 months before procedure (5) inflammatory, rheumatological or autoimmune disease (6) body mass index >35 kg/m2 (7) use of immunosuppresors or anticoagulants (8) active tumor (9) haematological disorder (10) Hip OA > Tonnis grade 3 (11) history of transmissible disease (12) patients unable for positioning for the procedure (13) patients living outside Rio de Janeiro metropolitan area

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
Bone marrow aspirate matrixBone marrow aspirate * Hyaluronic acid	Biological	Group A
Bone marrow aspirateBone marrow aspirate	Biological	Group B
Hyaluronic acidHyaluronic acid	Device	Group C

Primary outcome

Knee Society Score
Time frame: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
Western Ontario and Mcmaster (WOMAC) score
Time frame: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
Visual analog scale for pain
Time frame: before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, Brazil

21998913144

eduardobranco.joelho@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 Feb 2024. 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 Brazil. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Society Score (time frame: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06238934.

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 2 Feb 2024.