Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, cell therapy, stem cells, needle, bone marrow aspiration
Brief summary
Osteoarthritis (OA) is a leading cause of disability around the world. The aging population is only further increasing its prevalence. Moreover, increasing rates of obesity, as well as increasing athletic participation, is leading to patients developing OA at younger ages. Although total joint replacement is effective for alleviating the effects of OA for many patients, it is less beneficial for younger patients given the resultant reduced mobility and the \ 15 year life of a total joint replacement. Therefore, new options are needed for OA. One such option is bone marrow aspirate concentrate (BMAC) injection into the diseased joint. Several recent studies have shown significant symptomatic improvement from this therapy. Now, efforts are needed to better understand how to optimize this therapy, as numerous variables are involved, including: the volume of aspirate, adjuvant, aspiration location or locations, anesthetic, etc. Additionally, several FDA-approved needles are available for the aspiration step. Thus, the purpose of this study is to compare two different styles of FDA-approved needles--an open-ended trocar vs. a fenestrated blunt trocar--with respect to clinical outcomes, cell counts, and colony forming units. In addition to the comparison arms, taking these two groups together, this study will serve as prospective case series of 30 patients undergoing BMAC injection for knee osteoarthritis without a platelet-rich plasma (PRP) or any other adjuvant/carrier.
Interventions
PROCEDUREBMA cell therapy injection
The bone marrow aspirate will be injected into the affected knee joint.
Sponsors
Advanced Orthopaedic Specialists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age 18-79 * Patients have tried at least 6 weeks of conservative therapy including: activity modification, weight loss, brace, NSAIDs, corticosteroid injection * Radiographically confirmed Kellgren-Lawrence I-III OA (no bone-on-bone) * Patients can provide written informed consent
Exclusion criteria
* Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiencies * History of meniscal injury other than degenerative meniscal tears * Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way * Major mechanical axis deviation of more than 50% into either compartment (varus or valgus) * Intra-articular injection to affected knee within 3 months of intra-articular BMA injection or HA within 6 months * Body mass index of 35 or more; 18.5 or less (malnourished) * Active infection * Ongoing infectious diseases, including HIV and hepatitis * Clinically significant diabetes, cardiovascular, hepatic, or renal disease * Active malignancy, undergoing treatment, has undergone treatment, or has decline treatment * Use of anti-inflammatory medications, including herbal therapies, within 7 days of BMA * Use of anti-rheumatic medications, including methotrexate and other antimetabolites, within 3 months prior to study entry * History of radiation therapy * History of or current drug or alcohol use disorder * Current cigarette smokers * History of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee) * History of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone) * Pregnant or currently breast-feeding * Participation in a study of an experimental drug within 60 days of study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee injury and Osteoarthritis Outcome Score (KOOS) | Baseline, 1 week, 6 weeks, 6 months | Will assess for change in patient reported outcome measure that assesses symptoms, stiffness, pain, function, and quality of life from pre-procedure to post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Pain Scale (VAS) of affected knee | Baseline, 1 week, 6 weeks, 6 months | Will assess for change in patient reported pain scale of the patient's affected/treated knee from pre-procedure to post-procedure. |
| Change in Lysholm Score | Baseline, 1 week, 6 weeks, 6 months | Will assess for change in Lysholm patient reported outcome score from pre-procedure to post-procedure.. |
| Change in Tegner Score | Baseline, 1 week, 6 weeks, 6 months | Will assess for change in patient reported activity scale from pre-procedure to post-procedure. |
| Visual Analog Pain Scale (VAS) of aspiration site | Baseline (immediately after intervention), 1 week, 6 weeks, 6 months | Will assess the patient reported pain scale of the patient's aspiration site immediately after intervention and changes at the various time points. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cell counts and colony forming units | 1x, immediately after intervention | For each aspiration in the study, total nucleated cell counts and colony forming units will be analyzed. |
Countries
United States
Outcome results
None listed