- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05532150
Conservative Versus Operative - Frist Time Shoulder Dislocations
August 31, 2023 updated by: David P. Trofa, MD, Columbia University
Conservative Versus Operative Management of First Time Shoulder Dislocations
There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations.
This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
While primary anterior shoulder dislocations had been previously treated conservatively, growing concerns amidst recurrent shoulder instability have fueled interest in managing these injuries with surgery to mitigate the risk of future instability events.
While the significant literature investigating the rates of shoulder instability with initial operative management suggests improvement outcomes, there is limited level 1 evidence to support these implications.
A randomized-controlled trial (RCT) of 21 primary anterior shoulder dislocations undergoing arthroscopic Bankart repair or rehabilitation ( 9 operative vs 12 nonoperative; mean age: 22), found lower rates of recurrent shoulder instability (11% in operative vs 72% in non-operative; p=0.004) and higher Single Assessment Numeric Evaluation (SANE) scores (88 in operative vs 57 in non-operative; p<0.002) after 36 months of follow-up.
Similarly, another RCT of 76 patients (37 operative vs 39 non-operative; mean age: 22), found lower rates of recurrent shoulder instability (2.7% in operative vs 53.8% in non-operative; p<0.01) and higher Oxford assessment scores (70% with either 'excellent' or 'good' scores in operative group vs 26% with either 'excellent' or 'good' scores in non-operative group) after 10 years of follow-up.
A RCT of 31 patients (16 operative vs 15 non-operative; mean age: 22), found lower rates of recurrent instability ( 19% in operative vs 60% in non-operative; p=0.02) but no significantly different Western Ontario Score Indices (WOSI) (86% in operative vs 75% in non-operative; p=0.17) at a follow up of 79 months.
A RCT of 91 patients (44 operative vs 47 non-operative; mean age: 22), found lower rates of recurrent instability (2.3% in operative vs 19.1% in non-operative; p=0.01) and no significantly difference in WOSI (92.7% in operative vs 91.5% in non-operative; p>0.05) at 2 years follow-up.
A RCT of 40 patients (20 operative vs 20 non-operative; mean age: 21), found lower rates of recurrent shoulder instability (10% in operative vs 70% in non-operative; p=0.0001) and a higher WOSI (17.1 in operative vs 11.5 in non-operative; p=0.035) at 2 years follow-up.
The previous 5 RCT's represent the only level 1 evidence amidst a much larger proportion of lower-level evidence upon which much of the discussion of surgical vs non-operative management has been formulated.
Additionally, only 2 RCT's conducted power analyses to determine if their sample size was adequate, and they did not demonstrate unanimous results with patient reported outcomes as described above.
It is therefore critical to increase the amount of level 1 evidence on the topic of operative vs non-operative management of primary shoulder dislocations to better inform this debate.
This study aims to compare the incidence of recurrent shoulder instability and patient reported outcomes of patients with primary anterior shoulder dislocations managed with surgery (arthroscopic Bankart repair) compared to non-operative management (standardized rehabilitation protocol, control group).
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christian A Pearsall, BS, BA
- Phone Number: 251-377-6058
- Email: cap2263@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
Contact:
- Christian A Pearsall, BS, BA
- Phone Number: 251-377-6058
- Email: cap2263@cumc.columbia.edu
-
Contact:
- David P Trofa, MD
- Phone Number: 914-787-2279
- Email: dpt2103@cumc.columbia.edu
-
Principal Investigator:
- David P Trofa, MD
-
Sub-Investigator:
- Christian A Pearsall, BS, BA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Operative group
The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.
|
Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
|
Active Comparator: Non-operative group
The non-operative group will undergo physical therapy following a specific rehabilitation schedule.
|
Participants in this group will follow a specific physical therapy rehabilitation protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Western-Ontario Shoulder instability Index Score at 2 weeks
Time Frame: Baseline and 2 weeks
|
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.
|
Baseline and 2 weeks
|
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
|
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.
|
Baseline and 2 weeks
|
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
Time Frame: Baseline and 2 weeks
|
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.
|
Baseline and 2 weeks
|
Change in PROMIS Depression CAT at 2 weeks
Time Frame: Baseline and 2 weeks
|
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 weeks
|
Change in Western-Ontario Shoulder instability Index Score at 6 weeks
Time Frame: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Change in PROMIS PF CAT at 6 weeks
Time Frame: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Change in PROMIS PI CAT at at 6 weeks
Time Frame: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Change in PROMIS Depression CAT at 6 weeks
Time Frame: Baseline and 6 weeks
|
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
|
Change in Western-Ontario Shoulder instability Index Score at 3 months
Time Frame: Baseline and 3 months
|
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.
|
Baseline and 3 months
|
Change in PROMIS PF CAT at 3 months
Time Frame: Baseline and 3 months
|
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.
|
Baseline and 3 months
|
Change in PROMIS PI CAT at 3 months
Time Frame: Baseline and 3 months
|
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.
|
Baseline and 3 months
|
Change in PROMIS Depression CAT at 3 months
Time Frame: Baseline and 3 months
|
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 3 months
|
Change in Western-Ontario Shoulder instability Index Score at 6 months
Time Frame: Baseline and 6 months
|
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.
|
Baseline and 6 months
|
Change in PROMIS PF CAT at 6 months
Time Frame: Baseline and 6 months
|
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.
|
Baseline and 6 months
|
Change in PROMIS PI CAT at 6 months
Time Frame: Baseline and 6 months
|
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.
|
Baseline and 6 months
|
Change in PROMIS Depression CAT at 6 months
Time Frame: Baseline and 6 months
|
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
|
Change in Western-Ontario Shoulder instability Index Score at 1 year
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Change in PROMIS PF CAT at 1 year
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Change in PROMIS PI CAT at 1 year
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Change in PROMIS Depression CAT at 1 year
Time Frame: Baseline and 1 year
|
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 1 year
|
Change in Western-Ontario Shoulder instability Index Score at 2 years
Time Frame: Baseline and 2 years
|
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.
|
Baseline and 2 years
|
Change in PROMIS PF CAT at 2 years
Time Frame: Baseline and 2 years
|
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.
|
Baseline and 2 years
|
Change in PROMIS PI CAT at 2 years
Time Frame: Baseline and 2 years
|
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.
|
Baseline and 2 years
|
Change in PROMIS Depression CAT at 2 years
Time Frame: Baseline and 2 years
|
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
|
Change in Western-Ontario Shoulder instability Index Score at 5 years
Time Frame: Baseline and 5 years
|
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.
|
Baseline and 5 years
|
Change in PROMIS PF CAT at 5 years
Time Frame: Baseline and 5 years
|
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.
|
Baseline and 5 years
|
Change in PROMIS PI CAT at 5 years
Time Frame: Baseline and 5 years
|
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.
|
Baseline and 5 years
|
Change in PROMIS Depression CAT at 5 years
Time Frame: Baseline and 5 years
|
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 5 years
|
Change in Western-Ontario Shoulder instability Index Score at 10 years
Time Frame: Baseline and 10 years
|
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.
|
Baseline and 10 years
|
Change in PROMIS PF CAT at 10 years
Time Frame: Baseline and 10 years
|
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.
|
Baseline and 10 years
|
Change in PROMIS PI CAT at 10 years
Time Frame: Baseline and 10 years
|
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.
|
Baseline and 10 years
|
Change in PROMIS Depression CAT at 10 years
Time Frame: Baseline and 10 years
|
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 10 years
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Constant-Murley Score at 2 weeks
Time Frame: Baseline and 2 weeks
|
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.
|
Baseline and 2 weeks
|
Change in Constant-Murley Score at 6 weeks
Time Frame: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Change in Constant-Murley Score at 3 months
Time Frame: Baseline and 3 months
|
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.
|
Baseline and 3 months
|
Change in Constant-Murley Score at 6 months
Time Frame: Baseline and 6 months
|
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.
|
Baseline and 6 months
|
Change in Constant-Murley Score at 1 year
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Change in Constant-Murley Score at 2 years
Time Frame: Baseline and 2 years
|
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.
|
Baseline and 2 years
|
Change in Constant-Murley Score at 5 years
Time Frame: Baseline and 5 years
|
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.
|
Baseline and 5 years
|
Change in Constant-Murley Score at 10 years
Time Frame: Baseline and 10 years
|
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.
|
Baseline and 10 years
|
Change in Subjective Shoulder Value Score at 2 weeks
Time Frame: Baseline and 2 weeks
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
Baseline and 2 weeks
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Change in Subjective Shoulder Value Score at 6 weeks
Time Frame: Baseline and 6 weeks
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
Baseline and 6 weeks
|
Change in Subjective Shoulder Value Score at 3 months
Time Frame: Baseline and 3 months
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
Baseline and 3 months
|
Change in Subjective Shoulder Value Score at 6 months
Time Frame: Baseline and 6 months
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
Baseline and 6 months
|
Change in Subjective Shoulder Value Score at 1 year
Time Frame: Baseline and 1 year
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
Baseline and 1 year
|
Change in Subjective Shoulder Value Score at 2 years
Time Frame: Baseline and 2 years
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
Baseline and 2 years
|
Change in Subjective Shoulder Value Score at 5 years
Time Frame: Baseline and 5 years
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
Baseline and 5 years
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Change in Subjective Shoulder Value Score at 10 years
Time Frame: Baseline and 10 years
|
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
|
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
|
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
|
Baseline and 3 months
|
Change in Rowe Score at 6 months
Time Frame: Baseline and 6 months
|
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
|
Baseline and 6 months
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Change in Rowe Score at 1 year
Time Frame: Baseline and 1 year
|
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
|
Baseline and 1 year
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Change in Rowe Score at 2 years
Time Frame: Baseline and 2 years
|
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
|
Baseline and 2 years
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Change in Rowe Score at 5 years
Time Frame: Baseline and 5 years
|
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
|
Baseline and 5 years
|
Change in Rowe Score at 10 years
Time Frame: Baseline and 10 years
|
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
|
Baseline and 10 years
|
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
|
Time required to return to full activity level or return to sports after the initial injury, expressed in weeks
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Trofa, MD, Assistant Professor of Orthopedic Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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.
- 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. Erratum In: Am J Sports Med. 2022 Aug 11;:3635465221119998.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2023
Primary Completion (Estimated)
September 1, 2032
Study Completion (Estimated)
September 1, 2032
Study Registration Dates
First Submitted
September 4, 2022
First Submitted That Met QC Criteria
September 4, 2022
First Posted (Actual)
September 8, 2022
Study Record Updates
Last Update Posted (Actual)
September 1, 2023
Last Update Submitted That Met QC Criteria
August 31, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAU0965
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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