BMA vs Cortisone for Glenohumeral Osteoarthritis (BMAC)

July 17, 2022 updated by: Dr. Tim Dwyer, Women's College Hospital

A Randomized Trial of Cortisone Injection Versus Bone Marrow Aspirate Injection Therapy for Glenohumeral Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Women's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • BMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

University of Toronto

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 8, 2015

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0069-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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