BMA vs Cortisone for Glenohumeral Osteoarthritis

NCT03580148 | Completed Phase 2

• 1 other identifier: 2015-0069-B
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Shoulders

Keywords

osteoarthritis; glenohumeral joint; arthritis; shoulder

Outcome Measures

Primary Outcomes (1)

• Western Ontario Osteoarthritis of the Shoulder (WOOS) Index

  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.

Study Arms (2)

Cortisone

ACTIVE COMPARATOR

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

Bone Marrow Aspirate

ACTIVE COMPARATOR

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

Interventions

Cortisone DRUG

Patients randomized to receive this study intervention will undergo one ultrasound guided 80mg Depo Medrol GHJ injection

Also known as: 00030767 DEPO-MEDROL 80 MG/ML

Cortisone

Bone Marrow Aspirate BIOLOGICAL

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

Also known as: BMA

Bone Marrow Aspirate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead
• University of Toronto: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

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MeSH Terms

Conditions

Osteoarthritis; Arthritis

Interventions

Cortisone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Tim Dwyer, MBBS, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Tim Dwyer, Orthopaedic Surgeon, Principal Investigator

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 9, 2018
• Study Start: October 8, 2015
• Primary Completion: July 30, 2020
• Study Completion: November 23, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

CA (1)