Clinical TrialID 2121
BMA vs Cortisone for Glenohumeral Osteoarthritis
NCT03580148
Osteo Arthritis Shoulders
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2121
- Evidence Id
- 2121
- Core Evidence Id
- 2121
- Source Clinical Trial Id
- 2091
- Herb2 Clinical Trial Id
- HBCT002091
- Nct Id
- NCT03580148
- Title
- BMA vs Cortisone for Glenohumeral Osteoarthritis
- Status
- Completed
- Phase
- Phase 2|Phase 3
- Study Result
- No
- Study Condition
- Osteo Arthritis Shoulders
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Cortisone|BIOLOGICAL: Bone Marrow Aspirate
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 34
- Outcome Measure
- 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.
- Sponsor Collaborator
- Women's College Hospital|University of Toronto
- Funded By
- OTHER
- Location
- Women's College Hospital, Toronto, Ontario, M5S 1B2, Canada
- Other Id
- 2015-0069-B
- Start Date
- 2015-10-08
- Primary Completion Date
- 2020-07-30
- Completion Date
- 2021-11-23
- First Posted
- 2018-07-09
- Results First Posted
- Last Update Posted
- 2022-07-20
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03580148
- Title Cn
- Title En
- BMA vs Cortisone for Glenohumeral Osteoarthritis
- Bilingual Status
- semi_complete