Clinical trial NCT05532150: Conservative Versus Operative - First Time Shoulder Dislocations
Official title: Conservative Versus Operative Management of First Time Shoulder Dislocations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Dislocation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the physical therapy (conservative) group or the operative (surgery) group if they agree to participate in the study.
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Western-Ontario Shoulder instability Index Score at 2 weeks
timeFrame: Baseline and 2 weeks
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
measure: Change in PROMIS Pain Interference (PI) CAT at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in PROMIS Depression CAT at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Western-Ontario Shoulder instability Index Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in PROMIS PF CAT at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in PROMIS PI CAT at at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in PROMIS Depression CAT at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Western-Ontario Shoulder instability Index Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in PROMIS PF CAT at 3 months
timeFrame: Baseline and 3 months
measure: Change in PROMIS PI CAT at 3 months
timeFrame: Baseline and 3 months
measure: Change in PROMIS Depression CAT at 3 months
timeFrame: Baseline and 3 months
measure: Change in Western-Ontario Shoulder instability Index Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in PROMIS PF CAT at 6 months
timeFrame: Baseline and 6 months
measure: Change in PROMIS PI CAT at 6 months
timeFrame: Baseline and 6 months
measure: Change in PROMIS Depression CAT at 6 months
timeFrame: Baseline and 6 months
measure: Change in Western-Ontario Shoulder instability Index Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in PROMIS PF CAT at 1 year
timeFrame: Baseline and 1 year
measure: Change in PROMIS PI CAT at 1 year
timeFrame: Baseline and 1 year
measure: Change in PROMIS Depression CAT at 1 year
timeFrame: Baseline and 1 year
measure: Change in Western-Ontario Shoulder instability Index Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in PROMIS PF CAT at 2 years
timeFrame: Baseline and 2 years
measure: Change in PROMIS PI CAT at 2 years
timeFrame: Baseline and 2 years
measure: Change in PROMIS Depression CAT at 2 years
timeFrame: Baseline and 2 years
measure: Change in Western-Ontario Shoulder instability Index Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in PROMIS PF CAT at 5 years
timeFrame: Baseline and 5 years
measure: Change in PROMIS PI CAT at 5 years
timeFrame: Baseline and 5 years
measure: Change in PROMIS Depression CAT at 5 years
timeFrame: Baseline and 5 years
measure: Change in Western-Ontario Shoulder instability Index Score at 10 years
timeFrame: Baseline and 10 years
measure: Change in PROMIS PF CAT at 10 years
timeFrame: Baseline and 10 years
measure: Change in PROMIS PI CAT at 10 years
timeFrame: Baseline and 10 years
measure: Change in PROMIS Depression CAT at 10 years
timeFrame: Baseline and 10 years
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
Secondary outcomes:
measure: Change in Constant-Murley Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Constant-Murley Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Constant-Murley Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Constant-Murley Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Constant-Murley Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Constant-Murley Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Constant-Murley Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Constant-Murley Score at 10 years
timeFrame: Baseline and 10 years
measure: Change in Subjective Shoulder Value Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Subjective Shoulder Value Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Subjective Shoulder Value Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Subjective Shoulder Value Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Subjective Shoulder Value Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Subjective Shoulder Value Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Subjective Shoulder Value Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Subjective Shoulder Value Score at 10 years
timeFrame: Baseline and 10 years
measure: Change in Rowe Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Rowe Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Rowe Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Rowe Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Rowe Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Rowe Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Rowe Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Rowe Score at 10 years
timeFrame: Baseline and 10 years
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
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Orthopedic Surgery
name: David Trofa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.