Conservative Versus Operative - First Time Shoulder Dislocations

NCT05532150 | Not Yet Recruiting

• 1 other identifier: AAAU0965
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (33)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (25)

• Change in Constant-Murley Score at 2 weeks

  Baseline and 2 weeks

• Change in Constant-Murley Score at 6 weeks

  Baseline and 6 weeks

• Change in Constant-Murley Score at 3 months

  Baseline and 3 months

• Change in Constant-Murley Score at 6 months

  Baseline and 6 months

• Change in Constant-Murley Score at 1 year

  Baseline and 1 year

Study Arms (2)

Operative group

EXPERIMENTAL

The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.

Procedure: Arthroscopic Bankart repair

Non-operative group

ACTIVE COMPARATOR

The non-operative group will undergo physical therapy following a specific rehabilitation schedule.

Procedure: Physical therapy

Interventions

Arthroscopic Bankart repair PROCEDURE

Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.

Operative group

Physical therapy PROCEDURE

Participants in this group will follow a specific physical therapy rehabilitation protocol

Non-operative group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 12 and older
• seen by the Columbia University Shoulder Elbow and Sports Medicine Service
• first time anterior shoulder dislocation diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (7)

• 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: 32389771 BACKGROUND

• 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: 12130413 BACKGROUND

• 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: 33705240 BACKGROUND

• 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: 33596092 BACKGROUND

• 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: 17276217 BACKGROUND

• 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: 35148222 BACKGROUND

• 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.

  PMID: 15650667 BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• David P Trofa, MD

  Associate Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David P Trofa, MD

CONTACT

212 305 5974; dpt2103@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the physical therapy (conservative) group or the operative (surgery) group if they agree to participate in the study.

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)