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Recruiting NCT05985785

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

No phase Interventional Osteoarthritis of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous bone marrow aspirate concentrate (BMAC), Corticosteroid injections, Crossover Autologous bone marrow aspirate concentrate (BMAC).
Who it may be relevant to
Registry conditions: Osteoarthritis of the Knee. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial

Overview

Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.

Detailed description

The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up.

All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).

Interventions

  • Other Autologous bone marrow aspirate concentrate (BMAC)
    Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.
  • Drug Corticosteroid injections
    Current standard of treatment for OA of the knee is corticosteroid injection.
  • Other Crossover Autologous bone marrow aspirate concentrate (BMAC)
    Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)

Primary outcome measures

  • Visual analogue scale (VAS) for pain [Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)]
  • Intermittent and Constant Osteoarthritis Pain (ICOAP) [Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)]

Eligibility criteria

Inclusion criteria

  • Patients between the ages of 18-70
  • Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks
  • 7-day average pain score of at least 4 on VAS scale

Exclusion criteria

  • Systemic diseases (Diabetes, malignancies, infections, etc.)
  • Post-traumatic arthritis
  • Patient had intra-articular injection on affected knee in last three months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT05985785 · 21052504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗