Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial (OASIS)

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Dislocation; Anterior Shoulder Dislocation; Glenohumeral Dislocation
• Intervention / Treatment: Procedure: Arthroscopic Bankart repair procedure; Other: Post-Operative Rehabilitation; Procedure: Open Bankart; Procedure: Latarjet

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: 400 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Popchak, PhD, PT; Phone Number: (412) 383-6627; Email: ajp64@pitt.edu
• Study Contact Backup: Name: Jonathan Dickens, MD

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Not yet recruiting
      • Naval Medical Center
      • Contact: Lucas McDonald, MD; Email: lucas.s.mcdonald@gmail.com
      • Principal Investigator: Lucas McDonald, MD
  • Colorado
    • Fort Carson, Colorado, United States, 80913
      • Not yet recruiting
      • Evans Army Community Hospital
      • Contact: David Tennent, MD; Email: davidjtennent@gmail.com
      • Principal Investigator: David Tennent, MD
    • Vail, Colorado, United States, 81657
      • Recruiting
      • Steadman Clinic
      • Contact: Matthew Provencher, MD; Email: mprovencher@thesteadmanclinic.com
      • Principal Investigator: Matthew Provencher, MD
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • University of Connecticut Health Center
      • Contact: Cory Edgar, MD, PhD
      • Principal Investigator: Cory Edgar, MD, PhD
  • Maryland
    • Annapolis, Maryland, United States, 21402
      • Not yet recruiting
      • US Naval Health Clinic (Academy)
      • Contact: Lance LeClere, MD; Email: lancend15@gmail.com
      • Principal Investigator: Lance LeClere, MD
    • Bethesda, Maryland, United States, 20089
      • Not yet recruiting
      • Walter Reed National Military Medical Center
      • Contact: Kelly Kilcoyne, MD
      • Principal Investigator: Kelly Kilcoyne, MD
  • North Carolina
    • Camp Lejeune, North Carolina, United States, 28547
      • Not yet recruiting
      • Naval Medical Center Camp Lejeune
      • Contact: Kyle Nappo, MD; Email: kyle.nappo@gmail.com
      • Principal Investigator: Kyle Nappo, MD
    • Chapel Hill, North Carolina, United States, 27517
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Alex Creighton, MD
      • Principal Investigator: Alex Creighton, MD
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
      • Contact: Jonathan Dickens, MD; Email: jonathan.dickens@duke.edu
      • Principal Investigator: Jonathan Dickens, MD
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University
      • Contact: Brian Waterman, MD; Email: bwaterma@wakehealth.edu
      • Principal Investigator: Brian Waterman, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15203
      • Recruiting
      • University of Pittsburgh
      • Contact: Albert Lin, MD; Email: alin2@upmc.edu
      • Principal Investigator: Albert Lin, MD
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital- University Orthopedics
      • Principal Investigator: Brett Owens, MD
      • Contact: Brett Owens, MD; Email: owensbrett@gmail.com
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Not yet recruiting
      • San Antonio Military Medical Center
      • Contact: Andrew Sheean, MD; Email: ajsheean@gmail.com
      • Principal Investigator: Andrew Sheean, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • Not yet recruiting
      • University of Virginia
      • Contact: Stephen Brockmeier, MD; Email: SFB2E@hscmail.mcc.virginia.edu
      • Principal Investigator: Stephen Brockmeier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation; Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.	Procedure: Arthroscopic Bankart repair procedure; Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.; Other: Post-Operative Rehabilitation; Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
Experimental: Open Bankart/rehabilitation; Open Bankart surgery and post-operative rehabilitation.	Other: Post-Operative Rehabilitation; Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.; Procedure: Open Bankart; Open Bankart repair consists of anterior capsulorrhaphy with labral repair.
Experimental: Latarjet/rehabilitation; Latarjet surgical procedure and post-operative rehabilitation.	Other: Post-Operative Rehabilitation; Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.; Procedure: Latarjet; Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Shoulder Instability Index (WOSI)	The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.	3 months after randomization
Western Ontario Shoulder Instability Index (WOSI)	The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.	6 months after randomization
Western Ontario Shoulder Instability Index (WOSI)	The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.	12 months after randomization
Western Ontario Shoulder Instability Index (WOSI)	The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.	24 months after randomization
Time to Return to Pre-Injury Level of Activity	Time to return to pre-injury level military duty, work and sports.	Monthly starting at 3 months after randomization and continuing to 24 months
Recurrent Instability / Re-injury	Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.	3 months after randomization
Recurrent Instability / Re-injury	Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.	6 months after randomization
Recurrent Instability / Re-injury	Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.	12 months after randomization
Recurrent Instability / Re-injury	Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.	24 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single Assessment Numerical Evaluation (SANE)	The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.	3 months after surgery
Single Assessment Numerical Evaluation (SANE)	The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.	6 months after surgery
Single Assessment Numerical Evaluation (SANE)	The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.	12 months after surgery
Single Assessment Numerical Evaluation (SANE)	The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.	24 months after surgery
Brophy Shoulder Activity Level	The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.	3 months after randomization
Brophy Shoulder Activity Level	The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.	6 months after randomization
Brophy Shoulder Activity Level	The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.	12 months after randomization
Brophy Shoulder Activity Level	The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.	24 months after randomization
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)	The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.	3 months after randomization
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)	The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.	6 months after randomization
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)	The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.	12 months after randomization
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)	The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.	24 months after randomization
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10	The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.	3 months after surgery
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10	The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.	6 months after surgery
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10	The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.	12 months after surgery
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10	The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.	24 months after surgery
Tampa Scale for Kinesiophobia-11 (TSK-11)	The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.	3 months after surgery
Tampa Scale for Kinesiophobia-11 (TSK-11)	The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.	6 months after surgery
Tampa Scale for Kinesiophobia-11 (TSK-11)	The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.	12 months after surgery
Tampa Scale for Kinesiophobia-11 (TSK-11)	The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.	24 months after surgery
Brief Resilience Scale	The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.	3 months after randomization
Brief Resilience Scale	The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.	6 months after randomization
Brief Resilience Scale	The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.	12 months after randomization
Brief Resilience Scale	The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.	24 months after randomization
Patient Acceptable Symptom State (PASS)	The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.	3 months after randomization
Patient Acceptable Symptom State (PASS)	The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.	6 months after randomization
Patient Acceptable Symptom State (PASS)	The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.	12 months after randomization
Patient Acceptable Symptom State (PASS)	The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.	24 months after randomization
Functional Comorbidity Index	The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.	3 months after surgery
Functional Comorbidity Index	The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.	6 months after surgery
Functional Comorbidity Index	The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.	12 months after surgery
Functional Comorbidity Index	The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.	24 months after surgery
Passive Range of Motion of the Shoulder	The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.	3 months after surgery
Passive Range of Motion of the Shoulder	The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.	4 months after surgery
Passive Range of Motion of the Shoulder	The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.	6 months after surgery
Isometric Muscle Strength of the Shoulder	Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.	3 months after surgery
Isometric Muscle Strength of the Shoulder	Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.	4 months after surgery
Isometric Muscle Strength of the Shoulder	Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.	6 months after surgery
Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test	Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.	4 months after surgery
Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test	Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.	6 months after surgery
Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test	Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.	4 months after surgery
Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test	Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.	6 months after surgery
Performance on Functional Tests of the Upper Extremity - Push-ups	Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.	4 months after surgery
Performance on Functional Tests of the Upper Extremity - Push-ups	Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.	6 months after surgery
Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw	Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.	4 months after surgery
Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw	Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.	6 months after surgery
Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test	Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.	4 months after surgery
Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test	Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.	6 months after surgery
Clinical Measures after Surgical Stabilization - Pain	Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.	2 weeks after surgery
Clinical Measures after Surgical Stabilization - Pain	Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.	6 weeks +/- 2 weeks after surgery
Clinical Measures after Surgical Stabilization - Pain	Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.	3 months after surgery
Clinical Measures after Surgical Stabilization - Pain	Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.	5 months +/- month after surgery
Clinical Measures after Surgical Stabilization - Pain	Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.	12 months after surgery
Clinical Measures after Surgical Stabilization - Pain Medication Usage	Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.	2 weeks after surgery
Clinical Measures after Surgical Stabilization - Pain Medication Usage	Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.	6 weeks +/- 2 weeks after surgery
Clinical Measures after Surgical Stabilization - Pain Medication Usage	Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.	3 months after surgery
Clinical Measures after Surgical Stabilization - Pain Medication Usage	Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.	5 months +/- month after surgery
Clinical Measures after Surgical Stabilization - Pain Medication Usage	Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.	12 months after surgery
Clinical Measures after Surgical Stabilization - Use of Post-op Brace	Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.	2 weeks after surgery
Clinical Measures after Surgical Stabilization - Use of Post-op Brace	Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.	6 weeks +/- 2 weeks after surgery
Clinical Measures after Surgical Stabilization - Use of Post-op Brace	Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.	3 months after surgery
Clinical Measures after Surgical Stabilization - Use of Post-op Brace	Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.	5 months +/- month after surgery
Clinical Measures after Surgical Stabilization - Use of Post-op Brace	Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.	12 months after surgery
Clinical Measures after Surgical Stabilization - Wound Status	Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.	2 weeks after surgery
Clinical Measures after Surgical Stabilization - Wound Status	Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.	6 weeks +/- 2 weeks after surgery
Clinical Measures after Surgical Stabilization - Wound Status	Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.	3 months after surgery
Clinical Measures after Surgical Stabilization - Wound Status	Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.	5 months +/- month after surgery
Clinical Measures after Surgical Stabilization - Wound Status	Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.	12 months after surgery
Clinical Measures after Surgical Stabilization - Neurovascular status	Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.	2 weeks after surgery
Clinical Measures after Surgical Stabilization - Neurovascular status	Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.	6 weeks +/- 2 weeks after surgery
Clinical Measures after Surgical Stabilization - Neurovascular status	Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.	3 months after surgery
Clinical Measures after Surgical Stabilization - Neurovascular status	Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.	5 months +/- month after surgery
Clinical Measures after Surgical Stabilization - Neurovascular status	Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.	12 months after surgery
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests	Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.	2 weeks after surgery
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests	Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.	3 months after surgery
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests	Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.	5 months +/- month after surgery
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests	Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded	12 months after surgery

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Walter Reed National Military Medical Center
• Investigators: Principal Investigator: Adam Popchak, PhD, PT, University of Pittsburgh; Principal Investigator: Jonathan Dickens, MD, Duke University; Study Chair: James J Irrgang, PhD, PT, ATC, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Anterior Shoulder Instability; Glenoid Bone Loss; Stabilization Surgery; Return to Duty or Sport
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: PRO20030003; W81XWH-19-PROP-CTA (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A public-use version of the dataset will be constructed by the Data Coordinating Center (DCC) with contents to be determined jointly by the study PIs and the DCC Director. Copies of the public-use version of the dataset will be housed at the DCC on a secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or Statistical Analysis Software (SAS) datasets. Documentation will be in .pdf files.
• IPD Sharing Time Frame: The public-use version of the dataset will be made available 2 years after the study's main paper is published.
• IPD Sharing Access Criteria: Outside investigators wishing to conduct analyses using the data will submit a request with objectives, methods, and analysis plan to the PI and the Director of the DCC. Once the request is approved, the public-use version of the dataset, with documentation, will be sent by secure email using e-mail, ftp, or other mutually agreeable transmission method.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No