Osteo Arthritis Shoulders Clinical Trial
— BMACOfficial title:
A Randomized Trial of Cortisone Injection Versus Bone Marrow Aspirate Injection Therapy for Glenohumeral Osteoarthritis
Verified date | July 2022 |
Source | Women's College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | November 23, 2021 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Women's College Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Women's College Hospital | University of Toronto |
Canada,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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