Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis

Andrews Research & Education Foundation90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Pure PRP IICOMBINATION_PRODUCT

The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.

PureBMCCOMBINATION_PRODUCT

The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Andrews Research & Education Foundation

Gulf Breeze, Florida, United States

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements

Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain

Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

Secondary Outcomes

Subjective International Knee Documentation Committee Subjective Score (IKDC)

Pain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest

Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

Data from ClinicalTrials.gov

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