BMA vs Cortisone for Glenohumeral Osteoarthritis (BMAC)

• ClinicalTrials.gov Identifier: NCT03580148
• Recruitment Status: Active, not recruiting
• First Posted: July 9, 2018
• Last Update Posted: April 15, 2021
• Sponsor: Women's College Hospital
• Collaborator: University of Toronto
• Information provided by (Responsible Party): Dr. Tim Dwyer, Women's College Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteo Arthritis Shoulders	Drug: Cortisone; Biological: Bone Marrow Aspirate	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Cortisone Injection Versus Bone Marrow Aspirate Injection Therapy for Glenohumeral Osteoarthritis
• Study Start Date: October 8, 2015
• Actual Primary Completion Date: July 30, 2020
• Estimated Study Completion Date: October 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cortisone; Patients randomized to this arm will receive one (1) ultrasound guided injection of 80mg Depo Medrol cortisone in the glenohumeral joint of the affected shoulder. Procedure time of approximately 10 minutes	Drug: Cortisone; Patients randomized to receive this study intervention will undergo one ultrasound guided 80mg Depo Medrol GHJ injection; Other Name: 00030767 DEPO-MEDROL 80 MG/ML
Active Comparator: Bone Marrow Aspirate; Patients randomized to this arm will receive one (1) ultrasound injection of bone marrow aspirate, harvested from the posterior superior iliac spine, and injected into the glenohumeral joint of the affected shoulder. Procedure time of approximately 45 minutes	Biological: Bone Marrow Aspirate; 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 Name: BMA

Outcome Measures

Primary Outcome Measures :

1. Western Ontario Osteoarthritis of the Shoulder (WOOS) Index [ Time Frame: Survey administered at Baseline, and then change from baseline measured at 3 months post injection, 6 months post injection, and 12 months post injection with the survey being administered again at each of these time points. ]

   A 19 question, quality of life measurement tool for patients with osteoarthritis of the shoulder. WOOS assesses change in specific areas of daily life function from scores captured at pre injection baseline to those captured at 3, 6 and 12 month intervals.

   Patient responses are recorded with a mark placed on a scale by the patient for each of the 19 questions, with responses being measured quantitatively out of 100 per question, totaled per subsection (Physical Symptoms/600; Sports and Recreation/Work/500; Lifestyle/500;Emotions/300) , totaled out of 1900 overall. Marks placed at or near 0 on the scale indicate patient is not experiencing or affected by the symptom described in the question, while marks at or near 100 indicate the patient is very affected.

   Baseline survey completed on the day of the injection, repeated at 3, 6 and 12 months post injection to compare change in sub section score, and total score out of 1900 at the given time point, to the scores captured at baseline.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Men or women above the age of 18 - 65
• Primary diagnosis of glenohumeral joint osteoarthritis (Samilson and Prieto Stage 1, 2 or 3)
• Provision of informed consent

Exclusion Criteria:

• Prior condition (such as trauma, avascular necrosis, fracture, iatrogenic or chondrolysis) resulting in secondary osteoarthritis
• Previous surgical intervention for GHJ OA
• Previous injection of cortisone or other substance
• Inability to comply with rehabilitation or form completion
• Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
• WSIB involvement
• Lawsuit involvement

Contacts and Locations

Locations

Canada, Ontario

Women's College Hospital

Toronto, Ontario, Canada, M5S 1B2

Sponsors and Collaborators

Women's College Hospital

University of Toronto

Investigators

• Principal Investigator: Tim Dwyer, MBBS, PhD; Women's College Hospital

More Information

Publications:

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Charalambous CP, Tryfonidis M, Sadiq S, Hirst P, Paul A. Septic arthritis following intra-articular steroid injection of the knee--a survey of current practice regarding antiseptic technique used during intra-articular steroid injection of the knee. Clin Rheumatol. 2003 Dec;22(6):386-90. Epub 2003 Oct 15.

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• Responsible Party: Dr. Tim Dwyer, Dr. Tim Dwyer, Orthopaedic Surgeon, Principal Investigator, Women's College Hospital
• ClinicalTrials.gov Identifier: NCT03580148
• Other Study ID Numbers: 2015-0069-B
• First Posted: July 9, 2018
• Last Update Posted: April 15, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Tim Dwyer, Women's College Hospital:

osteoarthritis; glenohumeral joint; arthritis; shoulder

Additional relevant MeSH terms:

Arthritis; Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Cortisone; Methylprednisolone Acetate; Anti-Inflammatory Agents