Health TrialsbyHealthPanel

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

ConditionOsteoarthritis of the Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRush University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Systemic diseases (Diabetes, malignancies, infections, etc.)

Post-traumatic arthritis

Patient had intra-articular injection on affected knee in last three months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous bone marrow aspirate concentrate (BMAC)

    Other intervention

    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 intervention

    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)

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injectionsExperimental treatment 1 intervention
Group B: Corticosteroid injectionActive comparator 1 intervention
Group C: Crossover GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Visual analogue scale (VAS) for pain

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.

Time frame
Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
2

Intermittent and Constant Osteoarthritis Pain (ICOAP)

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

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

Knee Injury and Osteoarthritis Outcome Score (KOOS)

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)

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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