Conservative Versus Operative - First Time Shoulder Dislocations
Conservative Versus Operative Management of First Time Shoulder Dislocations
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: David P Trofa, MD
- Phone Number: 212 305 5974
- Email: dpt2103@cumc.columbia.edu
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Principal Investigator:
- David P Trofa, MD
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Contact:
- David P Trofa, MD
- Phone Number: 212-305-5974
- Email: dpt2103@cumc.columbia.edu
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients 12 and older
- seen by the Columbia University Shoulder Elbow and Sports Medicine Service
- first time anterior shoulder dislocation diagnosis
Exclusion Criteria:
- humeral avulsion during arthroscopy
- bony defect > 25% of glenoid surface
- general anesthesia contraindication
- previous shoulder surgery
- inability or unwillingness to adhere to study participate
- lost to follow up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Operative group
The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.
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Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
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Active Comparator: Non-operative group
The non-operative group will undergo physical therapy following a specific rehabilitation schedule.
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Participants in this group will follow a specific physical therapy rehabilitation protocol
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Western-Ontario Shoulder instability Index Score at 2 weeks
Time Frame: Baseline and 2 weeks
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 2 weeks
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Change in Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks
Time Frame: Baseline and 2 weeks
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 2 weeks
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Change in PROMIS Pain Interference (PI) CAT at 2 weeks
Time Frame: Baseline and 2 weeks
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 2 weeks
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Change in PROMIS Depression CAT at 2 weeks
Time Frame: Baseline and 2 weeks
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 2 weeks
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Change in Western-Ontario Shoulder instability Index Score at 6 weeks
Time Frame: Baseline and 6 weeks
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 6 weeks
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Change in PROMIS PF CAT at 6 weeks
Time Frame: Baseline and 6 weeks
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 6 weeks
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Change in PROMIS PI CAT at at 6 weeks
Time Frame: Baseline and 6 weeks
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 6 weeks
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Change in PROMIS Depression CAT at 6 weeks
Time Frame: Baseline and 6 weeks
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
|
Baseline and 6 weeks
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Change in Western-Ontario Shoulder instability Index Score at 3 months
Time Frame: Baseline and 3 months
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 3 months
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Change in PROMIS PF CAT at 3 months
Time Frame: Baseline and 3 months
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 3 months
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Change in PROMIS PI CAT at 3 months
Time Frame: Baseline and 3 months
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 3 months
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Change in PROMIS Depression CAT at 3 months
Time Frame: Baseline and 3 months
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 3 months
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Change in Western-Ontario Shoulder instability Index Score at 6 months
Time Frame: Baseline and 6 months
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 6 months
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Change in PROMIS PF CAT at 6 months
Time Frame: Baseline and 6 months
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 6 months
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Change in PROMIS PI CAT at 6 months
Time Frame: Baseline and 6 months
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 6 months
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Change in PROMIS Depression CAT at 6 months
Time Frame: Baseline and 6 months
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
|
Baseline and 6 months
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Change in Western-Ontario Shoulder instability Index Score at 1 year
Time Frame: Baseline and 1 year
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 1 year
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Change in PROMIS PF CAT at 1 year
Time Frame: Baseline and 1 year
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 1 year
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Change in PROMIS PI CAT at 1 year
Time Frame: Baseline and 1 year
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 1 year
|
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Change in PROMIS Depression CAT at 1 year
Time Frame: Baseline and 1 year
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 1 year
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Change in Western-Ontario Shoulder instability Index Score at 2 years
Time Frame: Baseline and 2 years
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 2 years
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Change in PROMIS PF CAT at 2 years
Time Frame: Baseline and 2 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 2 years
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Change in PROMIS PI CAT at 2 years
Time Frame: Baseline and 2 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 2 years
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Change in PROMIS Depression CAT at 2 years
Time Frame: Baseline and 2 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
|
Baseline and 2 years
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Change in Western-Ontario Shoulder instability Index Score at 5 years
Time Frame: Baseline and 5 years
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 5 years
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Change in PROMIS PF CAT at 5 years
Time Frame: Baseline and 5 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 5 years
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Change in PROMIS PI CAT at 5 years
Time Frame: Baseline and 5 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 5 years
|
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Change in PROMIS Depression CAT at 5 years
Time Frame: Baseline and 5 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 5 years
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Change in Western-Ontario Shoulder instability Index Score at 10 years
Time Frame: Baseline and 10 years
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A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 10 years
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Change in PROMIS PF CAT at 10 years
Time Frame: Baseline and 10 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 10 years
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Change in PROMIS PI CAT at 10 years
Time Frame: Baseline and 10 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 10 years
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Change in PROMIS Depression CAT at 10 years
Time Frame: Baseline and 10 years
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury.
A lower score indicates a better outcome.
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Baseline and 10 years
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Percentage of Participants with Recurrent Instability
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
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Percentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.
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2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Constant-Murley Score at 2 weeks
Time Frame: Baseline and 2 weeks
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 2 weeks
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Change in Constant-Murley Score at 6 weeks
Time Frame: Baseline and 6 weeks
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 6 weeks
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Change in Constant-Murley Score at 3 months
Time Frame: Baseline and 3 months
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 3 months
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Change in Constant-Murley Score at 6 months
Time Frame: Baseline and 6 months
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 6 months
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Change in Constant-Murley Score at 1 year
Time Frame: Baseline and 1 year
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 1 year
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Change in Constant-Murley Score at 2 years
Time Frame: Baseline and 2 years
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 2 years
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Change in Constant-Murley Score at 5 years
Time Frame: Baseline and 5 years
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 5 years
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Change in Constant-Murley Score at 10 years
Time Frame: Baseline and 10 years
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The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
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Baseline and 10 years
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Change in Subjective Shoulder Value Score at 2 weeks
Time Frame: Baseline and 2 weeks
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 2 weeks
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Change in Subjective Shoulder Value Score at 6 weeks
Time Frame: Baseline and 6 weeks
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 6 weeks
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Change in Subjective Shoulder Value Score at 3 months
Time Frame: Baseline and 3 months
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 3 months
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Change in Subjective Shoulder Value Score at 6 months
Time Frame: Baseline and 6 months
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 6 months
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Change in Subjective Shoulder Value Score at 1 year
Time Frame: Baseline and 1 year
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 1 year
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Change in Subjective Shoulder Value Score at 2 years
Time Frame: Baseline and 2 years
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 2 years
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Change in Subjective Shoulder Value Score at 5 years
Time Frame: Baseline and 5 years
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 5 years
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Change in Subjective Shoulder Value Score at 10 years
Time Frame: Baseline and 10 years
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Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
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Baseline and 10 years
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Change in Rowe Score at 2 weeks
Time Frame: Baseline and 2 weeks
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 2 weeks
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Change in Rowe Score at 6 weeks
Time Frame: Baseline and 6 weeks
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 6 weeks
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Change in Rowe Score at 3 months
Time Frame: Baseline and 3 months
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 3 months
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Change in Rowe Score at 6 months
Time Frame: Baseline and 6 months
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 6 months
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Change in Rowe Score at 1 year
Time Frame: Baseline and 1 year
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 1 year
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Change in Rowe Score at 2 years
Time Frame: Baseline and 2 years
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 2 years
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Change in Rowe Score at 5 years
Time Frame: Baseline and 5 years
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 5 years
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Change in Rowe Score at 10 years
Time Frame: Baseline and 10 years
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Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
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Baseline and 10 years
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Time to baseline functional status
Time Frame: Measured once per patient, depending on the time required to return to full activity (up to 10 years
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Time required to return to full activity level or return to sports after the initial injury, expressed in weeks
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Measured once per patient, depending on the time required to return to full activity (up to 10 years
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: David P Trofa, MD, Associate Professor of Orthopaedic Surgery
Publications and helpful links
General Publications
- Hurley ET, Manjunath AK, Bloom DA, Pauzenberger L, Mullett H, Alaia MJ, Strauss EJ. Arthroscopic Bankart Repair Versus Conservative Management for First-Time Traumatic Anterior Shoulder Instability: A Systematic Review and Meta-analysis. Arthroscopy. 2020 Sep;36(9):2526-2532. doi: 10.1016/j.arthro.2020.04.046. Epub 2020 May 8.
- Bottoni CR, Wilckens JH, DeBerardino TM, D'Alleyrand JC, Rooney RC, Harpstrite JK, Arciero RA. A prospective, randomized evaluation of arthroscopic stabilization versus nonoperative treatment in patients with acute, traumatic, first-time shoulder dislocations. Am J Sports Med. 2002 Jul-Aug;30(4):576-80. doi: 10.1177/03635465020300041801.
- Pouges C, Hardy A, Vervoort T, Amouyel T, Duriez P, Lalanne C, Szymanski C, Deken V, Chantelot C, Upex P, Maynou C. Arthroscopic Bankart Repair Versus Immobilization for First Episode of Anterior Shoulder Dislocation Before the Age of 25: A Randomized Controlled Trial. Am J Sports Med. 2021 Apr;49(5):1166-1174. doi: 10.1177/0363546521996381. Epub 2021 Mar 11.
- Kirkley A, Werstine R, Ratjek A, Griffin S. Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder: long-term evaluation. Arthroscopy. 2005 Jan;21(1):55-63. doi: 10.1016/j.arthro.2004.09.018.
- Jakobsen BW, Johannsen HV, Suder P, Sojbjerg JO. Primary repair versus conservative treatment of first-time traumatic anterior dislocation of the shoulder: a randomized study with 10-year follow-up. Arthroscopy. 2007 Feb;23(2):118-23. doi: 10.1016/j.arthro.2006.11.004.
- Belk JW, Wharton BR, Houck DA, Bravman JT, Kraeutler MJ, Mayer B, Noonan TJ, Seidl AJ, Frank RM, McCarty EC. Shoulder Stabilization Versus Immobilization for First-Time Anterior Shoulder Dislocation: A Systematic Review and Meta-analysis of Level 1 Randomized Controlled Trials. Am J Sports Med. 2023 May;51(6):1634-1643. doi: 10.1177/03635465211065403. Epub 2022 Feb 11.
- Minkus M, Konigshausen M, Pauly S, Maier D, Mauch F, Stein T, Greiner S, Moursy M, Scheibel M. Immobilization in External Rotation and Abduction Versus Arthroscopic Stabilization After First-Time Anterior Shoulder Dislocation: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2021 Mar;49(4):857-865. doi: 10.1177/0363546520987823. Epub 2021 Feb 17.
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AAAU0965
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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