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NCT Number: NCT05985785

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Adam Yanke, MD

SUB_INVESTIGATOR

Carla M Edwards, PhD

CONTACT

[email protected]

312-563-5735

Jorge Chahla, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous bone marrow aspirate concentrate (BMAC)

Other

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.

Corticosteroid injections

Drug

Current standard of treatment for OA of the knee is corticosteroid injection.

Crossover Autologous bone marrow aspirate concentrate (BMAC)

Other

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 outcomes

  1. Visual analogue scale (VAS) for pain

    Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.

  2. Intermittent and Constant Osteoarthritis Pain (ICOAP)

    Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

    13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain.

  3. 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)

    The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)

Study contacts

Contact information is provided by the study sponsor or research team.

Carla M. Edwards, PhD

CONTACT

[email protected]

312-563-5735

Jorge Chahla, MD

CONTACT

[email protected]

(312) 432-2818

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Acronym: BMAC

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2023
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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