Clinical trial NCT03289416: Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis
Official title: Efficacy of Bone Marrow Aspirate Concentrate Compared With Platelet Rich Plasma for the Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: knee
osteoarthritis
platelet rich plasma (PRP)
bone marrow concentrate (BMC)
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: EmCyte Corporation
name: BioSciences Research Associates, Inc
First posted: 2017-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either a PRP intervention group or the BMC intervention group. Knee pain and function outcomes of enrolled patients in the two groups will be compared to determine which treatment is more effective in treating knee osteoarthritis.
Primary purpose: TREATMENT

Brief summary: This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.

Detailed description: While PRP shows promise in helping restore function to these patients, there are still concerns with PRP's long term outcomes. Another option that has become more popular for physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA), which use's undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. These cells have the ability to replicate into a multiple different tissue types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts.

Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. However, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of BMA for osteoarthritis treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female age 18-80 years
* Knee osteoarthritis
* Subjects must present with pain or swelling to target knee for at least 4 months
* Kellgren-Lawrence score between 1 and 3 upon x-ray evaluation
* Must be willing and able to provide informed consent
* Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

* Major mechanical axis deviation of more than 50% into either compartment (varus or valgus )
* Have had a corticosteroid injection within 3 months or a hyaluronic acid injection within 6 months
* History of the following medical conditions:
* diabetes
* autoimmune disorders
* disorders requiring immunosuppression
* rheumatoid arthritis
* hemophilic arthropathy
* infectious arthritis
* Charcot's knee
* Paget's disease of the femur or tibia
* Cancer
* Ongoing infectious disease
* Significant cardiovascular, renal or hepatic disease

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes:
measure: Subjective International Knee Documentation Committee Subjective Score (IKDC)
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Foundation
state: Florida
Study officials:
affiliation: Andrews Institute for Orthopaedic & Sports Medicine
name: Joshua Hackel, MD
role: PRINCIPAL_INVESTIGATOR
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