BMA vs Cortisone for Glenohumeral Osteoarthritis
Condition: Osteo Arthritis Shoulders
MeSH terms: Arthritis; Osteoarthritis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized trial seeks to investigate the difference if any between cortisone injection
      versus bone marrow aspirate injection in the glenohumeral joint of patients with confirmed
      osteoarthritis. The investigators hope that results from a prospective randomized controlled
      pilot study on bone marrow aspirate (BMA) glenohumeral joint (GHJ) injections will provide
      valuable early information on an alternative treatment for GHJ osteoarthritis (OA). This
      novel study will also contribute clinical data to the growing pool of research around BMA in
      the treatment of osteoarthritis. This study has the potential to uncover a new and more
      effective therapy to add to the arsenal of an orthopaedic surgeon in the management of GHJ
      OA. This would provide improved care and treatment for those disabled by GHJ OA.
      Additionally, this knowledge would be applicable to a variety of medical practitioners who
      treat GHJ OA from the general orthopaedic surgeon to pain subspecialists.
    

Detailed description: 
      Glenohumeral joint (GHJ) osteoarthritis (OA) is a painful, progressive and debilitating
      condition that impairs quality of life. Currently, the only "cure" for arthritis is total
      joint replacement. This is a major operation that carries with it significant risks including
      infection, stiffness, limited range of motion, peri-prosthetic fracture and loosening.
      Furthermore, there are permanent post-operative restrictions, and in young or active people
      there is a significant rate of early revision surgery. Therefore, the goal of early shoulder
      OA management is symptom control, and postponement or prevention of the need for joint
      replacement.

      Initial management options include physical therapy, pain-control medications, and
      intra-articular injections. Corticosteroid injections are the most commonly utilized
      injectables used in GHJ OA, with previous studies reporting good, short term pain relief and
      clinical improvement with corticosteroid injections for shoulder OA. However, corticosteroid
      injections may damage the collagen matrix of tendons and ligaments around the shoulder with
      repeated injections. Intra-articular hyaluronic acid (HA) injections have been proposed as an
      alternative to corticosteroid injections, and have demonstrated a clinically significant
      improvement in pain and function, albeit with a limited effect size.

      Bone marrow aspirate concentrate (BMA) injections is a relatively recent option for the
      treatment of OA. BMA is a biological product that is produced through the centrifugation of
      the patient's own bone marrow, producing a cellular equivalent to iliac crest bone graft.
      This aspirate has been shown to contain, among other nucleated cells, mesenchymal stem cells
      (MSC's) and hematopoietic stem cells (which can directly convert to stromal
      MSC's).Furthermore, this minimally invasive procedure can be conducted as an outpatient
      procedure, saving operating room time.

      Preliminary studies on intra-articular knee injections of BMA for early OA have reported
      statistically significant benefits in improved pain scores and function, with few adverse
      effects. The mechanism of action is likely through paracrine effects exerted by MSCs with the
      upshot being anti-inflammatory and potentially regenerative capabilities. These results are
      encouraging for the use of BMA in the shoulder, which is a non-weight bearing joint.
      Therefore, the investigators believe that the clinical improvements seen with BMA injections
      for knee OA will also be seen in the shoulder to an equal or greater extent.

      To date there are no trials investigating injectable stem cell therapies in the shoulder. The
      investigators aim to conduct a randomized controlled study to test the safety and efficacy of
      BMA injections for the treatment of early to mid-stage GHJ OA.

      1.2 Significance of Current Study

      Results from a prospective randomized controlled pilot study on BMA GHJ injections will
      provide valuable early information on an alternative treatment for GHJ OA. This novel study
      will also contribute clinical data to the growing pool of research around BMA in the
      treatment of osteoarthritis.

      This research group is proposing a randomized clinical trial prospectively comparing BMA GHJ
      injections versus Depo Medrol Cortisone GHJ injections. This study will include comprehensive
      clinical, functional and joint specific patient outcome scores.

      After a comprehensive literature review, to the investigators knowledge, there are no studies
      on the efficacy of BMA injections for management of GHJ OA. Thus, this study will be the
      first to report on safety, efficacy and costs associated with BMA injections.

      This innovative study has the potential to uncover a new and more effective therapy to add to
      the arsenal of an orthopaedic surgeon in the management of GHJ OA. This would provide
      improved care and treatment for people disabled by GHJ OA. Additionally, this knowledge would
      be applicable to a variety of medical practitioners who treat GHJ OA from the general
      orthopaedic surgeon to pain subspecialists.
    

Intervention name(s): Cortisone; Bone Marrow Aspirate
Intervention type(s): Drug; Biological
Intervention description(s): Patients randomized to receive this study intervention will undergo one ultrasound guided 80mg Depo Medrol GHJ injection; Patients randomized to receive this study intervention will have, under sterile conditions and after injection of local anesthetic, 10 mls of bone marrow aspirate taken from the posterior superior iliac spine and injected under ultrasound guidance to the glenohumeral joint
Other intervention name(s): 00030767 DEPO-MEDROL 80 MG/ML; BMA
Intervention MeSH terms: Cortisone; Methylprednisolone Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis; glenohumeral joint; arthritis; shoulder