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BMA vs Cortisone for Glenohumeral Osteoarthritis (BMAC)

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ClinicalTrials.gov Identifier: NCT03580148
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Dr. Tim Dwyer, Women's College Hospital

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580148


Contacts
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Contact: Tim Dwyer, MBBS, PhD 416-323-6482 tim.dwyer@wchospital.ca
Contact: Elyse Watkins 4163237526 elyse.watkins@wchospital.ca

Locations
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Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Tim Dwyer, MBBS, PhD    416-323-6482    tim.dwyer@wchospital.ca   
Contact: Elyse Watkins    4163237526    elyse.watkins@wchospital.ca   
Sponsors and Collaborators
Women's College Hospital
University of Toronto
Investigators
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Principal Investigator: Tim Dwyer, MBBS, PhD Women's College Hospital

Publications:

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Responsible Party: Dr. Tim Dwyer, Dr. Tim Dwyer, Orthopaedic Surgeon, Principal Investigator, Women's College Hospital
ClinicalTrials.gov Identifier: NCT03580148     History of Changes
Other Study ID Numbers: 2015-0069-B
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone
Cortisone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents