Conservative Versus Operative - Frist Time Shoulder Dislocations

Shoulder Dislocation Clinical Trial

Official title:

Conservative Versus Operative Management of First Time Shoulder Dislocations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05532150
• Other study ID #: AAAU0965
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: September 2032

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: Christian A Pearsall, BS, BA
• Phone: 251-377-6058
• Email: cap2263[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2032
• Est. primary completion date: September 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Procedure:
• Arthroscopic Bankart repair
Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
• Physical therapy
Participants in this group will follow a specific physical therapy rehabilitation protocol

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Am J Sports Med. 2022 Aug 11;:3635465221119998. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 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
Primary	Change in PROMIS Pain Interference (PI) CAT at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in PROMIS PF CAT at 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
Primary	Change in PROMIS PI CAT at at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in PROMIS PF CAT at 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
Primary	Change in PROMIS PI CAT at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in PROMIS PF CAT at 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
Primary	Change in PROMIS PI CAT at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in PROMIS PF CAT at 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
Primary	Change in PROMIS PI CAT at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in PROMIS PF CAT at 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
Primary	Change in PROMIS PI CAT at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in PROMIS PF CAT at 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
Primary	Change in PROMIS PI CAT at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Change in Western-Ontario Shoulder instability Index Score at 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
Primary	Change in PROMIS PF CAT at 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
Primary	Change in PROMIS PI CAT at 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
Primary	Change in PROMIS Depression CAT at 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
Primary	Percentage of Participants with Recurrent Instability	Percentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.	2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Constant-Murley Score at 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
Secondary	Change in Subjective Shoulder Value Score at 2 weeks	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 2 weeks
Secondary	Change in Subjective Shoulder Value Score at 6 weeks	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 6 weeks
Secondary	Change in Subjective Shoulder Value Score at 3 months	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 3 months
Secondary	Change in Subjective Shoulder Value Score at 6 months	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 6 months
Secondary	Change in Subjective Shoulder Value Score at 1 year	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 1 year
Secondary	Change in Subjective Shoulder Value Score at 2 years	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 2 years
Secondary	Change in Subjective Shoulder Value Score at 5 years	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 5 years
Secondary	Change in Subjective Shoulder Value Score at 10 years	Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline	Baseline and 10 years
Secondary	Change in Rowe Score at 2 weeks	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 2 weeks
Secondary	Change in Rowe Score at 6 weeks	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 6 weeks
Secondary	Change in Rowe Score at 3 months	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 3 months
Secondary	Change in Rowe Score at 6 months	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 6 months
Secondary	Change in Rowe Score at 1 year	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 1 year
Secondary	Change in Rowe Score at 2 years	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 2 years
Secondary	Change in Rowe Score at 5 years	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 5 years
Secondary	Change in Rowe Score at 10 years	Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function	Baseline and 10 years
Secondary	Time to baseline functional status	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