Clinical trial NCT04809064: Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss: the OASIS Trial
Official title: Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss: the OASIS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Dislocation
Glenohumeral Dislocation
Anterior Shoulder Dislocation
Keywords: Anterior Shoulder Instability
Glenoid Bone Loss
Stabilization Surgery
Return to Duty or Sport
Rehabilitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
First posted: 2021-03-22
Enrollment: 400
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss.

Detailed description: The objective of this clinical trial is to determine the optimal surgical procedure and post-operative rehabilitation strategy for treatment of military personnel and civilians with shoulder instability and subcritical bone loss. Investigators will conduct a randomized, controlled trial comparing arthroscropic Bankart with remplissage/rehabilitation versus open Bankart/rehabilitation versus Latarjet/rehabilitation.

Aim 1: The investigators will determine the effects of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion versus open Bankart versus Latarjet on patient reported outcomes (Western Ontario Shoulder Instability score \[WOSI\]), time to Return to Duty/Activity (RTD/A) at pre-injury levels, and recurrent instability/re-injury at 6 months, 1 and 2 years.

Aim 2: The investigators will determine if participation in rehabilitation that optimizes range of motion, strength, and functional performance predicts successful RTD/A, WOSI score, and recurrent instability at 6 months, 1, and 2 years.

Subject Population: Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss and plans to return to physically demanding work or sports, without multi-directional instability, concomitant shoulder pathologies (e.g. rotator cuff tears, motor nerve lesion, fractures, osteoarthritis \> Samilson Pietro grade 2), neuromuscular conditions including seizures, a history of shoulder surgery related to any intraarticular soft tissue, and vascular injury will be eligible to participate.

Study / Experimental Design: Randomized controlled trial (Aim 1), Prospective cohort (Aim 2).

Methodology: 450 individuals will be randomized to arthroscopic Bankart with remplissage of a Hill-Sachs lesion/rehabilitation vs. open Bankart/rehabilitation vs. open Latarjet/rehabilitation.

To address Aim 1, individuals with traumatic anterior shoulder instability with subcritical bone loss will be randomized to arthroscopic Bankart repair with remplissageof a Hill-Sachs lesion, or open Bankart, or Latarjet. To address Aim 2, all individuals will enter into rehabilitation with specific instructions for the first 12 weeks dependent on the surgical arm to which they are randomized. After week 12, all rehabilitation programs will be similar and progressed based upon the results of interim testing at 3, 4, and 6 months.

Participants will be followed for 24 months, with primary outcomes consisting of patient-reported physical function and time to return to pre-injury military duty, work and sports. Secondary outcomes will include shoulder-specific and generic patient-reported measures of physical function and health related quality of life and recurrent instability.

Eligibility criteria: Inclusion Criteria:

* Civilians and military personnel ages 17 to 50
* Traumatic anterior shoulder dislocation
* Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan

Exclusion Criteria:

* Chronic, non-traumatic multi-directional instability based on clinical exam.
* Concurrent shoulder injury (e.g. rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade \>2).
* Prior instability or rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery).
* Humeral sided bone lesion (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed.
* Neuromuscular and other movement control pathologies including seizures.
* Vascular injury associated with the shoulder trauma.
* Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines.
* Does not plan to return to pre-injury levels of work, sports or military duty.

Primary outcomes:
measure: Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 3 months after randomization
measure: Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 6 months after randomization
measure: Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 12 months after randomization
measure: Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 24 months after randomization
measure: Time to Return to Pre-Injury Level of Activity
timeFrame: Monthly starting at 3 months after randomization and continuing to 24 months
measure: Recurrent Instability / Re-injury
timeFrame: 3 months after randomization
measure: Recurrent Instability / Re-injury
timeFrame: 6 months after randomization
measure: Recurrent Instability / Re-injury
timeFrame: 12 months after randomization
measure: Recurrent Instability / Re-injury
timeFrame: 24 months after randomization
Secondary outcomes:
measure: Single Assessment Numerical Evaluation (SANE)
timeFrame: 3 months after surgery
measure: Single Assessment Numerical Evaluation (SANE)
timeFrame: 6 months after surgery
measure: Single Assessment Numerical Evaluation (SANE)
timeFrame: 12 months after surgery
measure: Single Assessment Numerical Evaluation (SANE)
timeFrame: 24 months after surgery
measure: Brophy Shoulder Activity Level
timeFrame: 3 months after randomization
measure: Brophy Shoulder Activity Level
timeFrame: 6 months after randomization
measure: Brophy Shoulder Activity Level
timeFrame: 12 months after randomization
measure: Brophy Shoulder Activity Level
timeFrame: 24 months after randomization
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
timeFrame: 3 months after randomization
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
timeFrame: 6 months after randomization
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
timeFrame: 12 months after randomization
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
timeFrame: 24 months after randomization
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
timeFrame: 3 months after surgery
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
timeFrame: 6 months after surgery
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
timeFrame: 12 months after surgery
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
timeFrame: 24 months after surgery
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: 3 months after surgery
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: 6 months after surgery
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: 12 months after surgery
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: 24 months after surgery
measure: Brief Resilience Scale
timeFrame: 3 months after randomization
measure: Brief Resilience Scale
timeFrame: 6 months after randomization
measure: Brief Resilience Scale
timeFrame: 12 months after randomization
measure: Brief Resilience Scale
timeFrame: 24 months after randomization
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 3 months after randomization
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 6 months after randomization
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 12 months after randomization
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 24 months after randomization
measure: Functional Comorbidity Index
timeFrame: 3 months after surgery
measure: Functional Comorbidity Index
timeFrame: 6 months after surgery
measure: Functional Comorbidity Index
timeFrame: 12 months after surgery
measure: Functional Comorbidity Index
timeFrame: 24 months after surgery
measure: Passive Range of Motion of the Shoulder
timeFrame: 3 months after surgery
measure: Passive Range of Motion of the Shoulder
timeFrame: 4 months after surgery
measure: Passive Range of Motion of the Shoulder
timeFrame: 6 months after surgery
measure: Isometric Muscle Strength of the Shoulder
timeFrame: 3 months after surgery
measure: Isometric Muscle Strength of the Shoulder
timeFrame: 4 months after surgery
measure: Isometric Muscle Strength of the Shoulder
timeFrame: 6 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test
timeFrame: 4 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test
timeFrame: 6 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test
timeFrame: 4 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test
timeFrame: 6 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Push-ups
timeFrame: 4 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Push-ups
timeFrame: 6 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw
timeFrame: 4 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw
timeFrame: 6 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test
timeFrame: 4 months after surgery
measure: Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test
timeFrame: 6 months after surgery
measure: Clinical Measures after Surgical Stabilization - Pain
timeFrame: 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Pain
timeFrame: 6 weeks +/- 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Pain
timeFrame: 3 months after surgery
measure: Clinical Measures after Surgical Stabilization - Pain
timeFrame: 5 months +/- month after surgery
measure: Clinical Measures after Surgical Stabilization - Pain
timeFrame: 12 months after surgery
measure: Clinical Measures after Surgical Stabilization - Pain Medication Usage
timeFrame: 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Pain Medication Usage
timeFrame: 6 weeks +/- 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Pain Medication Usage
timeFrame: 3 months after surgery
measure: Clinical Measures after Surgical Stabilization - Pain Medication Usage
timeFrame: 5 months +/- month after surgery
measure: Clinical Measures after Surgical Stabilization - Pain Medication Usage
timeFrame: 12 months after surgery
measure: Clinical Measures after Surgical Stabilization - Use of Post-op Brace
timeFrame: 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Use of Post-op Brace
timeFrame: 6 weeks +/- 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Use of Post-op Brace
timeFrame: 3 months after surgery
measure: Clinical Measures after Surgical Stabilization - Use of Post-op Brace
timeFrame: 5 months +/- month after surgery
measure: Clinical Measures after Surgical Stabilization - Use of Post-op Brace
timeFrame: 12 months after surgery
measure: Clinical Measures after Surgical Stabilization - Wound Status
timeFrame: 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Wound Status
timeFrame: 6 weeks +/- 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Wound Status
timeFrame: 3 months after surgery
measure: Clinical Measures after Surgical Stabilization - Wound Status
timeFrame: 5 months +/- month after surgery
measure: Clinical Measures after Surgical Stabilization - Wound Status
timeFrame: 12 months after surgery
measure: Clinical Measures after Surgical Stabilization - Neurovascular status
timeFrame: 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Neurovascular status
timeFrame: 6 weeks +/- 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Neurovascular status
timeFrame: 3 months after surgery
measure: Clinical Measures after Surgical Stabilization - Neurovascular status
timeFrame: 5 months +/- month after surgery
measure: Clinical Measures after Surgical Stabilization - Neurovascular status
timeFrame: 12 months after surgery
measure: Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
timeFrame: 2 weeks after surgery
measure: Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
timeFrame: 3 months after surgery
measure: Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
timeFrame: 5 months +/- month after surgery
measure: Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Mayo Clinic
state: Arizona
city: San Diego
country: United States
facility: Naval Medical Center
state: California
city: Fort Carson
country: United States
facility: Evans Army Community Hospital
state: Colorado
city: Vail
country: United States
facility: Steadman Clinic
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Annapolis
country: United States
facility: US Naval Health Clinic (Academy)
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Camp Lejeune
country: United States
facility: Naval Medical Center Camp Lejeune
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University, Wexner Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital - University Orthopedics
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Pittsburgh
name: Adam Popchak, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Jonathan Dickens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: James J Irrgang, PhD, PT, ATC
role: STUDY_CHAIR
References: