Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects
      nearly 27 million people in the United States. This disease leads to the breakdown of the
      cartilage surfaces of the joints, which serve as the connection points between the bones of
      the body, causing a large amount of pain and disability in patients. Increasing the number of
      available treatment options for osteoarthritis is becoming increasingly more important as
      Americans continue to age. Using stem cells taken from bone marrow is one of the
      non-operative treatments that has been gaining popularity in the recent past. This study aims
      to clarify how this procedure should best be done by comparing stem cell concentrations and
      patient outcomes (short and long term) in patients who have stem cells taken from one area vs
      two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).
    

Detailed description: 
      Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects
      nearly 27 million people in the United States. This disease leads to the breakdown of the
      cartilage surfaces of the joints, which serve as the connection points between the bones of
      the body, causing a large amount of pain and disability in patients. Increasing the number of
      available treatment options for osteoarthritis is becoming increasingly more important as
      Americans continue to age. Using stem cells taken from bone marrow is one of the
      non-operative treatments that has been gaining popularity in the recent past. This study aims
      to clarify how this procedure should best be done by comparing stem cell concentrations and
      patient outcomes (short and long term) in patients who have stem cells taken from one area vs
      two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).

      This research study involves the participant being randomly placed into one of two groups;
      one group will have cells taken from one hip, and the other will have cells taken from both
      hips. Both of these approaches are performed in clinics currently, and both are considered to
      be standard of care. All bone marrow collected for the purposes of this study will be
      obtained by the principal investigator while performing the standard procedure. In obtaining
      these sample the physicians will abide by the standard of care set forth for the Bone Marrow
      Aspiration Concentrate procedure.
    

Intervention name(s): Unilateral Bone Marrow Procurement; Bilateral Bone Marrow Procurement
Intervention type(s): Procedure; Procedure
Intervention description(s): A total of 61cc of bone marrow will be procured under ultrasound guidance from one posterior superior iliac spine (PSIS) via 3 passes, each at least 1 cm apart, through the bone cortex. In each pass, investigators will obtain 2.3cc of BMA with a 60cc syringes.; 30.5cc of bone marrow will be obtained under ultrasound guidance from each posterior superior iliac spine (PSIS) with 3 passes, at least 1 cm apart, per side (10.17cc per pass) using 60cc syringes. The collection from each PSIS will be combined to yield a total of 61cc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Orthopedics