Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05532150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2022-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Versus Operative - First Time Shoulder Dislocations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012783', 'term': 'Shoulder Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to either the physical therapy (conservative) group or the operative (surgery) group if they agree to participate in the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2032-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2022-09-04', 'studyFirstSubmitQcDate': '2022-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Western-Ontario Shoulder instability Index Score at 2 weeks', 'timeFrame': 'Baseline and 2 weeks', 'description': "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."}, {'measure': 'Change in Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks', 'timeFrame': 'Baseline and 2 weeks', 'description': "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."}, {'measure': 'Change in PROMIS Pain Interference (PI) CAT at 2 weeks', 'timeFrame': 'Baseline and 2 weeks', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 2 weeks', 'timeFrame': 'Baseline and 2 weeks', 'description': "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."}, {'measure': 'Change in Western-Ontario Shoulder instability Index Score at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': "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."}, {'measure': 'Change in PROMIS PF CAT at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': "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."}, {'measure': 'Change in PROMIS PI CAT at at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': "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."}, {'measure': 'Change in Western-Ontario Shoulder instability Index Score at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': "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."}, {'measure': 'Change in PROMIS PF CAT at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': "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."}, {'measure': 'Change in PROMIS PI CAT at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': "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."}, {'measure': 'Change in Western-Ontario Shoulder instability Index Score at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': "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."}, {'measure': 'Change in PROMIS PF CAT at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': "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."}, {'measure': 'Change in PROMIS PI CAT at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': "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."}, {'measure': 'Change in Western-Ontario Shoulder instability Index Score at 1 year', 'timeFrame': 'Baseline and 1 year', 'description': "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."}, {'measure': 'Change in PROMIS PF CAT at 1 year', 'timeFrame': 'Baseline and 1 year', 'description': "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."}, {'measure': 'Change in PROMIS PI CAT at 1 year', 'timeFrame': 'Baseline and 1 year', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 1 year', 'timeFrame': 'Baseline and 1 year', 'description': "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."}, {'measure': 'Change in Western-Ontario Shoulder instability Index Score at 2 years', 'timeFrame': 'Baseline and 2 years', 'description': "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."}, {'measure': 'Change in PROMIS PF CAT at 2 years', 'timeFrame': 'Baseline and 2 years', 'description': "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."}, {'measure': 'Change in PROMIS PI CAT at 2 years', 'timeFrame': 'Baseline and 2 years', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 2 years', 'timeFrame': 'Baseline and 2 years', 'description': "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."}, {'measure': 'Change in Western-Ontario Shoulder instability Index Score at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': "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."}, {'measure': 'Change in PROMIS PF CAT at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': "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."}, {'measure': 'Change in PROMIS PI CAT at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': "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."}, {'measure': 'Change in Western-Ontario Shoulder instability Index Score at 10 years', 'timeFrame': 'Baseline and 10 years', 'description': "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."}, {'measure': 'Change in PROMIS PF CAT at 10 years', 'timeFrame': 'Baseline and 10 years', 'description': "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."}, {'measure': 'Change in PROMIS PI CAT at 10 years', 'timeFrame': 'Baseline and 10 years', 'description': "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."}, {'measure': 'Change in PROMIS Depression CAT at 10 years', 'timeFrame': 'Baseline and 10 years', 'description': "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."}, {'measure': 'Percentage of Participants with Recurrent Instability', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years', 'description': 'Percentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.'}], 'secondaryOutcomes': [{'measure': 'Change in Constant-Murley Score at 2 weeks', 'timeFrame': 'Baseline and 2 weeks', 'description': '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.'}, {'measure': 'Change in Constant-Murley Score at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.'}, {'measure': 'Change in Constant-Murley Score at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': '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.'}, {'measure': 'Change in Constant-Murley Score at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Change in Constant-Murley Score at 1 year', 'timeFrame': 'Baseline and 1 year', 'description': '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.'}, {'measure': 'Change in Constant-Murley Score at 2 years', 'timeFrame': 'Baseline and 2 years', 'description': '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.'}, {'measure': 'Change in Constant-Murley Score at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': '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.'}, {'measure': 'Change in Constant-Murley Score at 10 years', 'timeFrame': 'Baseline and 10 years', 'description': '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.'}, {'measure': 'Change in Subjective Shoulder Value Score at 2 weeks', 'timeFrame': 'Baseline and 2 weeks', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Subjective Shoulder Value Score at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Subjective Shoulder Value Score at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Subjective Shoulder Value Score at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Subjective Shoulder Value Score at 1 year', 'timeFrame': 'Baseline and 1 year', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Subjective Shoulder Value Score at 2 years', 'timeFrame': 'Baseline and 2 years', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Subjective Shoulder Value Score at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Subjective Shoulder Value Score at 10 years', 'timeFrame': 'Baseline and 10 years', 'description': "Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline"}, {'measure': 'Change in Rowe Score at 2 weeks', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Change in Rowe Score at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Change in Rowe Score at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Change in Rowe Score at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Change in Rowe Score at 1 year', 'timeFrame': 'Baseline and 1 year', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Change in Rowe Score at 2 years', 'timeFrame': 'Baseline and 2 years', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Change in Rowe Score at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Change in Rowe Score at 10 years', 'timeFrame': 'Baseline and 10 years', 'description': 'Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function'}, {'measure': 'Time to baseline functional status', 'timeFrame': 'Measured once per patient, depending on the time required to return to full activity (up to 10 years', 'description': 'Time required to return to full activity level or return to sports after the initial injury, expressed in weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Dislocation']}, 'referencesModule': {'references': [{'pmid': '32389771', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12130413', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '33705240', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33596092', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17276217', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35148222', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15650667', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients 12 and older\n* seen by the Columbia University Shoulder Elbow and Sports Medicine Service\n* first time anterior shoulder dislocation diagnosis\n\nExclusion Criteria:\n\n* humeral avulsion during arthroscopy\n* bony defect \\> 25% of glenoid surface\n* general anesthesia contraindication\n* previous shoulder surgery\n* inability or unwillingness to adhere to study participate\n* lost to follow up'}, 'identificationModule': {'nctId': 'NCT05532150', 'briefTitle': 'Conservative Versus Operative - First Time Shoulder Dislocations', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Conservative Versus Operative Management of First Time Shoulder Dislocations', 'orgStudyIdInfo': {'id': 'AAAU0965'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Operative group', 'description': 'The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.', 'interventionNames': ['Procedure: Arthroscopic Bankart repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-operative group', 'description': 'The non-operative group will undergo physical therapy following a specific rehabilitation schedule.', 'interventionNames': ['Procedure: Physical therapy']}], 'interventions': [{'name': 'Arthroscopic Bankart repair', 'type': 'PROCEDURE', 'description': 'Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.', 'armGroupLabels': ['Operative group']}, {'name': 'Physical therapy', 'type': 'PROCEDURE', 'description': 'Participants in this group will follow a specific physical therapy rehabilitation protocol', 'armGroupLabels': ['Non-operative group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'David P Trofa, MD', 'role': 'CONTACT', 'email': 'dpt2103@cumc.columbia.edu', 'phone': '212-305-5974'}, {'name': 'David P Trofa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'David P Trofa, MD', 'role': 'CONTACT', 'email': 'dpt2103@cumc.columbia.edu', 'phone': '212 305 5974'}], 'overallOfficials': [{'name': 'David P Trofa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Orthopaedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}