Sponsor study identifier
observational
45
1 country
1
Study Start
January 28, 2019
Actual (reported)Primary Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A comprehensive understanding of healthy shoulder motion is a valuable contribution to the academic literature and provides a basis of comparison for various shoulder pathologies and treatments. However, the medical community is primarily interested in how pathology affects shoulder function and the underlying musculoskeletal reasons for impaired function associated with specific pathologies. Rotator cuff tears (RCT) provide an excellent model to study shoulder biomechanics because RCTs can cause significant functional impairment and can be quantified in size and location using standard clinical imaging techniques. Upon completion of this study a comprehensive database of three-dimensional joint angles and EMG patterns of the structures of the shoulder joint complex of dominant and non-dominant during common activities of daily living will be available for healthy subjects and those of subjects whose dominant limbs are impaired by rotator cuff tears. These data will show normal muscle activations and movement patterns required to complete activities of daily living and compare them to the movement, and muscle activation patterns of persons who exhibit muscular and movement dysfunction due to rotator cuff tears.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2019
Actual (reported)September 12, 2020
Actual (reported)October 1, 2020
Actual (reported)December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Range of motion
Measure range of motion in abduction, forward flexion, external rotation in neutral position and external rotation at 90 degrees abductions with corresponding rotator cuff muscle activation patterns
At enrollment
Activities of Daily Living
Measure glenohumeral joint angles and rotator cuff muscle activation patterns during the performance of prescribed activities of daily living
At enrollment
Patient reported outcome
At enrollment
Healthy subjects who meet the inclusion criteria and participate in data collection for the purpose of developing and validating the biomechanical models used to track scapular motion
Healthy subjects who meet the inclusion criteria and participate in data collection for comparison of shoulder motion and muscle activation patterns with RCT subjects
Subjects who have sustained a major rotator cuff tear
Patients between 50 and 70 years old, inclusive, who present with chronic right shoulder pain with a documented right rotator cuff tear will be screened for eligibility and participation. Rotator cuff tear subjects will be recruited under consultation with physicians from their patient populations. Patient charts will be assessed by study investigators to ensure they meet inclusion/exclusion criteria prior to consent. Healthy subjects will be recruited by flyer and word of mouth from the surrounding general population. Healthy subjects will be of similar demographics to the rotator cuff tear subjects.
MORE Foundation
Phoenix, Arizona, 85023, United States
Marc D Jacofsky, PhD
More Foundation
First Submitted
September 12, 2020
First Posted
October 1, 2020
Study Start
January 28, 2019
Actual (reported)Primary Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot
Contact the study team to confirm eligibility.
Study Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 6, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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