Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Not Applicable

Recruiting

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: Corticosteroid injections; Other: Autologous bone marrow aspirate concentrate (BMAC); Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)

• Registration Number: NCT05985785
• Lead Sponsor: Rush University Medical Center

Brief Summary

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)).

Study Timeline

• Study Start: 2022-07-19
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid injection	Corticosteroid injections	Corticosteroid injection group (ARM 2) will receive a sham incision.
Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections	Autologous bone marrow aspirate concentrate (BMAC)	Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. "Autologous" means that the subject is receiving back their own cells that were collected.
Crossover Group	Crossover Autologous bone marrow aspirate concentrate (BMAC)	Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).

Primary Outcome Measures

Name	Time	Method
Intermittent and Constant Osteoarthritis Pain (ICOAP)	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.
Visual analogue scale (VAS) for pain	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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)

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States