Osteoarthritis of the Knee
Conditions
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)).
Interventions
OTHERAutologous 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.
Current standard of treatment for OA of the knee is corticosteroid injection.
OTHERCrossover 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)
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
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)).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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) |
Countries
United States
Contacts
CONTACTCarla M. Edwards, PhD
CONTACTJorge Chahla, MD
PRINCIPAL_INVESTIGATORJorge Chahla, MD
Rush University Medical Center Associate Professor and Surgeon
Outcome results
None listed